Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

Atherosclerotic Cardiovascular Disease Clinical Trial

— VICTORION-2P  

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05030428
• Other study ID #: CKJX839B12302
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 23, 2021
• Est. completion date: October 13, 2027

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

Description:

Purpose of this study is to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1, Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17006
• Est. completion date: October 13, 2027
• Est. primary completion date: October 13, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Fasting LDL-C = 70 mg/dL at randomization visit

2. Stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin greater than or equal to 40 mg QD or rosuvastatin greater than or equal to 20 mg QD

3. Established CV disease defined as ANY of the following three conditions

1. Spontaneous Myocardial infarction = 4 weeks from screening visit

2. History of ischemic stroke occurred = 4 weeks prior to the Screening visit

3. Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent claudication with ankle brachial index (ABI) < 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease.

Exclusion Criteria:

1. Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 4 weeks before screening visit

2. Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit

3. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months after the first study visit

4. Heart failure NYHA class III or IV

5. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver

6. Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years

7. Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years

8. History of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit

9. Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Inclisiran sodium 300 mg
Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit
• Placebo
Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad de Buenos Aires
Argentina	Novartis Investigative Site	Ciudad de Salta	Provincia De Salta
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Corrientes
Argentina	Novartis Investigative Site	Formosa
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Posadas	Misiones
Argentina	Novartis Investigative Site	Quilmes	Buenos Aires
Argentina	Novartis Investigative Site	Ramos Mejia	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	San Martin	Buenos Aires
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Tucuman	San Miguel De Tucuman
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	Auchenflower	Queensland
Australia	Novartis Investigative Site	Bedford Park	South Australia
Australia	Novartis Investigative Site	Botany	New South Wales
Australia	Novartis Investigative Site	Bundaberg West	Queensland
Australia	Novartis Investigative Site	Clayton	Victoria
Australia	Novartis Investigative Site	Geelong	Victoria
Australia	Novartis Investigative Site	Leabrook	South Australia
Australia	Novartis Investigative Site	Liverpool	New South Wales
Australia	Novartis Investigative Site	Malvern East	Victoria
Australia	Novartis Investigative Site	Milton	Queensland
Australia	Novartis Investigative Site	Murdoch	Western Australia
Australia	Novartis Investigative Site	Nedlands	Western Australia
Australia	Novartis Investigative Site	New Lambton Heights	New South Wales
Australia	Novartis Investigative Site	Richmond
Australia	Novartis Investigative Site	Woodville	South Australia
Australia	Novartis Investigative Site	Woolloongabba	Queensland
Austria	Novartis Investigative Site	Braunau
Austria	Novartis Investigative Site	Graz
Belgium	Novartis Investigative Site	Antwerpen
Belgium	Novartis Investigative Site	Brasschaat
Belgium	Novartis Investigative Site	Brugge
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Charleroi
Belgium	Novartis Investigative Site	Edegem
Belgium	Novartis Investigative Site	Genk
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Kortrijk
Belgium	Novartis Investigative Site	La Louviere
Belgium	Novartis Investigative Site	Roeselare
Belgium	Novartis Investigative Site	Ronse
Belgium	Novartis Investigative Site	Yvoir
Brazil	Novartis Investigative Site	Aracaju	SE
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Blumenau	Santa Catarina
Brazil	Novartis Investigative Site	Brasilia	DF
Brazil	Novartis Investigative Site	Brasilia	DF
Brazil	Novartis Investigative Site	Campinas	SP
Brazil	Novartis Investigative Site	Campinas
Brazil	Novartis Investigative Site	Curitiba	PR
Brazil	Novartis Investigative Site	Maceio	AL
Brazil	Novartis Investigative Site	Pelotas	RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Ribeirao Preto	SP
Brazil	Novartis Investigative Site	Rio de Janeiro
Brazil	Novartis Investigative Site	Salvador	BA
Brazil	Novartis Investigative Site	Santo Andre	SP
Brazil	Novartis Investigative Site	Santo Andre	SP
Brazil	Novartis Investigative Site	Santo Andre	Sao Paulo
Brazil	Novartis Investigative Site	Sao Bernardo do Campo	SP
Brazil	Novartis Investigative Site	Sao Jose
Brazil	Novartis Investigative Site	Sao Jose Do Rio Preto	SP
Brazil	Novartis Investigative Site	Sao Jose do Rio Preto	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sao Paulo
Brazil	Novartis Investigative Site	Uberlandia	Minas Gerais
Brazil	Novartis Investigative Site	Vitoria	ES
Bulgaria	Novartis Investigative Site	Burgas
Bulgaria	Novartis Investigative Site	Haskovo
Bulgaria	Novartis Investigative Site	Kyustendil
Bulgaria	Novartis Investigative Site	Montana
Bulgaria	Novartis Investigative Site	Pernik
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Ruse
Bulgaria	Novartis Investigative Site	Ruse
Bulgaria	Novartis Investigative Site	Sandanski	Blagoevgrad
Bulgaria	Novartis Investigative Site	Sliven
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Stamboliyski
Bulgaria	Novartis Investigative Site	Stara Zagora
Bulgaria	Novartis Investigative Site	Stara Zagora
Bulgaria	Novartis Investigative Site	Veliko Tarnovo
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Cambridge	Ontario
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Greenfield Park	Quebec
Canada	Novartis Investigative Site	Guelph	Ontario
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Moncton	New Brunswick
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Newmarket	Ontario
Canada	Novartis Investigative Site	North Vancouver	British Columbia
Canada	Novartis Investigative Site	Oakville	Ontario
Canada	Novartis Investigative Site	Peterborough	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Sainte Foy	Quebec
Canada	Novartis Investigative Site	Sainte Foy	Quebec
Canada	Novartis Investigative Site	Sarnia	Ontario
Canada	Novartis Investigative Site	Scarborough	Ontario
Canada	Novartis Investigative Site	Scarborough	Ontario
Canada	Novartis Investigative Site	St Jerome	Quebec
Canada	Novartis Investigative Site	Stoufville	Ontario
Canada	Novartis Investigative Site	Sydney	Nova Scotia
Canada	Novartis Investigative Site	Terrebonne	Quebec
Canada	Novartis Investigative Site	Trois Rivieres	Quebec
Canada	Novartis Investigative Site	Vancouver	British Columbia
Canada	Novartis Investigative Site	Vancouver	British Columbia
Canada	Novartis Investigative Site	Victoria	British Columbia
Canada	Novartis Investigative Site	Victoria	British Columbia
Canada	Novartis Investigative Site	Victoria	British Columbia
Canada	Novartis Investigative Site	Winnipeg	Manitoba
Canada	Novartis Investigative Site	Winnipeg	Manitoba
Chile	Novartis Investigative Site	La Serena	Region De Coquimbo
Chile	Novartis Investigative Site	Osorno	Los Lagos
Chile	Novartis Investigative Site	Santiago
Chile	Novartis Investigative Site	Santiago
Chile	Novartis Investigative Site	Santiago	Region Metropolitana
Chile	Novartis Investigative Site	Santiago	RM
Chile	Novartis Investigative Site	Temuco	Region De La Araucania
Chile	Novartis Investigative Site	Victoria	Araucania
Chile	Novartis Investigative Site	Vina Del Mar	Valparaiso
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Changchun	Jilin
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Changzhou	Jiangsu
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Chongqing	Chongqing
China	Novartis Investigative Site	Dalian	Liaoning
China	Novartis Investigative Site	Foshan	Guangdong
China	Novartis Investigative Site	Guang Zhou
China	Novartis Investigative Site	Guangzhou
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Guangzhou City	Guangdong
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Harbin	Heilongjiang
China	Novartis Investigative Site	Hohhot	Inner Mongolia
China	Novartis Investigative Site	Jiangyin	Jiangsu
China	Novartis Investigative Site	Jinan
China	Novartis Investigative Site	Jinan	Shandong
China	Novartis Investigative Site	Jingzhou	Hubei
China	Novartis Investigative Site	Lishui City	Zhejiang
China	Novartis Investigative Site	Nanchang	Jiangxi
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanning	Guangxi
China	Novartis Investigative Site	Pingxiang	Jiangxi
China	Novartis Investigative Site	Shanghai	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Suzhou	Jiangsu
China	Novartis Investigative Site	Taiyuan	Shanxi
China	Novartis Investigative Site	Taizhou	Zhejiang
China	Novartis Investigative Site	Tianjin	Tianjin
China	Novartis Investigative Site	Tianjin
China	Novartis Investigative Site	Urumqi	Xinjiang
China	Novartis Investigative Site	Wuhan	Hubei
China	Novartis Investigative Site	Wuhan	Hubei
China	Novartis Investigative Site	Wuhan	Hubei
China	Novartis Investigative Site	Wulumuqi	Xinjiang
China	Novartis Investigative Site	Xiamen
China	Novartis Investigative Site	Xian	Shanxi
China	Novartis Investigative Site	Xuzhou	Jiangsu
Colombia	Novartis Investigative Site	Barranquilla	Atlantico
Colombia	Novartis Investigative Site	Barranquilla
Colombia	Novartis Investigative Site	Bogota
Colombia	Novartis Investigative Site	Cali
Colombia	Novartis Investigative Site	Cali	Valle Del Cauca
Colombia	Novartis Investigative Site	Cali	Valle Del Cauca
Colombia	Novartis Investigative Site	Cartagena	Bolivar
Colombia	Novartis Investigative Site	Florida Blanca
Colombia	Novartis Investigative Site	Manizales	Caldas
Colombia	Novartis Investigative Site	Medellin	Antioquia
Colombia	Novartis Investigative Site	Medellin	Antioquia
Colombia	Novartis Investigative Site	Pereira	Risaralda
Croatia	Novartis Investigative Site	Cakovec
Croatia	Novartis Investigative Site	Krapinske toplice
Croatia	Novartis Investigative Site	Opatija
Croatia	Novartis Investigative Site	Osijek
Croatia	Novartis Investigative Site	Rijeka
Croatia	Novartis Investigative Site	Slavonski Brod
Croatia	Novartis Investigative Site	Split
Croatia	Novartis Investigative Site	Zagreb
Czechia	Novartis Investigative Site	Bedihost
Czechia	Novartis Investigative Site	Brno	Czech Republic
Czechia	Novartis Investigative Site	Brno	Czech Republic
Czechia	Novartis Investigative Site	Brno
Czechia	Novartis Investigative Site	Brno Bohunice
Czechia	Novartis Investigative Site	Cesky Krumlov	Czech Republic
Czechia	Novartis Investigative Site	Hodonin
Czechia	Novartis Investigative Site	Hradec Kralove
Czechia	Novartis Investigative Site	JIhlava
Czechia	Novartis Investigative Site	Louny	Czech Republic
Czechia	Novartis Investigative Site	Marianske lazne
Czechia	Novartis Investigative Site	Nachod
Czechia	Novartis Investigative Site	Ostrava
Czechia	Novartis Investigative Site	Ostrava
Czechia	Novartis Investigative Site	Ostrava
Czechia	Novartis Investigative Site	Pardubice
Czechia	Novartis Investigative Site	Policska	CZE
Czechia	Novartis Investigative Site	Praha
Czechia	Novartis Investigative Site	Praha 10
Czechia	Novartis Investigative Site	Praha 5
Czechia	Novartis Investigative Site	Prerov
Czechia	Novartis Investigative Site	Pribram VIII
Czechia	Novartis Investigative Site	Slany	Czech Republic
Czechia	Novartis Investigative Site	Svitavy	Czech Republic
Czechia	Novartis Investigative Site	Trebic	Czech Republic
Czechia	Novartis Investigative Site	Uherske Hradiste
Czechia	Novartis Investigative Site	Zlin
Denmark	Novartis Investigative Site	Arhus C
Denmark	Novartis Investigative Site	Esbjerg
Denmark	Novartis Investigative Site	Glostrup
Denmark	Novartis Investigative Site	Herlev
Denmark	Novartis Investigative Site	Herning	Central Jutland
Denmark	Novartis Investigative Site	Hjorring
Denmark	Novartis Investigative Site	Roskilde
Denmark	Novartis Investigative Site	Svendborg
Denmark	Novartis Investigative Site	Viborg
Estonia	Novartis Investigative Site	Parnu
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
Estonia	Novartis Investigative Site	Tartu
Finland	Novartis Investigative Site	Helsinki
Finland	Novartis Investigative Site	Jyvaskyla
Finland	Novartis Investigative Site	Kuopio	Pohjois Savo
Finland	Novartis Investigative Site	Turku
Finland	Novartis Investigative Site	Turku
France	Novartis Investigative Site	Amiens
France	Novartis Investigative Site	Beziers Cedex
France	Novartis Investigative Site	Brest
France	Novartis Investigative Site	Chambray les Tours
France	Novartis Investigative Site	Cholet
France	Novartis Investigative Site	Clermont Ferrand
France	Novartis Investigative Site	Corbeil Essonnes
France	Novartis Investigative Site	Grenoble Cedex 9
France	Novartis Investigative Site	Le Coudray
France	Novartis Investigative Site	Lille
France	Novartis Investigative Site	Lille
France	Novartis Investigative Site	Limoges
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Metz
France	Novartis Investigative Site	Montauban
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Nice	Cedex1
France	Novartis Investigative Site	Nimes
France	Novartis Investigative Site	Orleans
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris 13
France	Novartis Investigative Site	Paris cedex 10
France	Novartis Investigative Site	Pau Cedex
France	Novartis Investigative Site	Pessac Cedex
France	Novartis Investigative Site	Poitiers
France	Novartis Investigative Site	Reims
France	Novartis Investigative Site	Rennes
France	Novartis Investigative Site	Toulouse 4
France	Novartis Investigative Site	Tourcoing
France	Novartis Investigative Site	Valenciennes
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Ioannina	GR
Greece	Novartis Investigative Site	Larissa	GR
Greece	Novartis Investigative Site	Thessaloniki
Hungary	Novartis Investigative Site	Baja
Hungary	Novartis Investigative Site	Balassagyarmat
Hungary	Novartis Investigative Site	Balatonfured
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Kalocsa
Hungary	Novartis Investigative Site	Kecskemet
Hungary	Novartis Investigative Site	Kistarcsa
Hungary	Novartis Investigative Site	Komarom
Hungary	Novartis Investigative Site	Nagykanizsa
Hungary	Novartis Investigative Site	Oroshaza
Hungary	Novartis Investigative Site	Oroshaza	Csongrad
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Pécs
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szekszard
Hungary	Novartis Investigative Site	Szolnok
Hungary	Novartis Investigative Site	Zalaegerszeg
Iceland	Novartis Investigative Site	Kopavogur
Iceland	Novartis Investigative Site	Reykjavik
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Aligarh	Uttar Pradesh
India	Novartis Investigative Site	Belgavi
India	Novartis Investigative Site	Bengaluru	Karnataka
India	Novartis Investigative Site	Bikaner	Rajasthan
India	Novartis Investigative Site	Chennai	Tamil Nadu
India	Novartis Investigative Site	Coimbatore	Tamil Nadu
India	Novartis Investigative Site	Coimbatore
India	Novartis Investigative Site	DehraDun	Uttarakhand
India	Novartis Investigative Site	Dehradun	Uttrakhand
India	Novartis Investigative Site	Ghaziabad	Uttar Pradesh
India	Novartis Investigative Site	Guntur	Andhrapradesh
India	Novartis Investigative Site	Hyderabad	Andhra Pradesh
India	Novartis Investigative Site	Hyderabad	Telangana
India	Novartis Investigative Site	Indore	Madhyapradesh
India	Novartis Investigative Site	Kanpur	Uttar Pradesh
India	Novartis Investigative Site	Kochi	Kerala
India	Novartis Investigative Site	Kochi	Kerala
India	Novartis Investigative Site	Kolkata	West Bengal
India	Novartis Investigative Site	Kozhikode	Kerala
India	Novartis Investigative Site	Lucknow	Uttar Pradesh
India	Novartis Investigative Site	Madurai	Tamil Nadu
India	Novartis Investigative Site	Manipal	Karnataka
India	Novartis Investigative Site	Mumbai	Maharashtra
India	Novartis Investigative Site	Mysore	Karnataka
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nashik	Maharashtra
India	Novartis Investigative Site	New Delhi	Delhi
India	Novartis Investigative Site	New Delhi	Delhi
India	Novartis Investigative Site	New Delhi
India	Novartis Investigative Site	New Delhi
India	Novartis Investigative Site	Puducherry
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Rudrapur	Uttarakhand
India	Novartis Investigative Site	Secunderabad	Telangana
India	Novartis Investigative Site	Vadodara	Gujarat
India	Novartis Investigative Site	Varanasi	Uttar Pradesh
Israel	Novartis Investigative Site	Ashdod
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Nahariya
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Ramat Gan
Israel	Novartis Investigative Site	Safed
Israel	Novartis Investigative Site	Tel Giborim, Holon
Israel	Novartis Investigative Site	Zerifin	HaMerkaz
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Brescia	BS
Italy	Novartis Investigative Site	Cona	FE
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Grosseto	GR
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Modena	MO
Italy	Novartis Investigative Site	Pordenone	PN
Italy	Novartis Investigative Site	Pozzilli	IS
Italy	Novartis Investigative Site	Rozzano	MI
Italy	Novartis Investigative Site	Sassari
Italy	Novartis Investigative Site	Siena	SI
Italy	Novartis Investigative Site	Torino	TO
Japan	Novartis Investigative Site	Chikushino-city	Fukuka
Japan	Novartis Investigative Site	Fujisawa	Kanagawa
Japan	Novartis Investigative Site	Izumisano-city	Osaka
Japan	Novartis Investigative Site	Kanazawa	Ishikawa
Japan	Novartis Investigative Site	Kawaguchi	Saitama
Japan	Novartis Investigative Site	Komatsu	Ishikawa
Japan	Novartis Investigative Site	Nagaoka-city	Niigata
Japan	Novartis Investigative Site	Nagasaki
Japan	Novartis Investigative Site	Odawara	Kanagawa
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Toyota	Aichi
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Kenya	Novartis Investigative Site	Nairobi
Korea, Republic of	Novartis Investigative Site	Bundang Gu	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Cheongju si	Chungcheongbuk Do
Korea, Republic of	Novartis Investigative Site	Daegu	Dalseo Gu
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Daejeon
Korea, Republic of	Novartis Investigative Site	Gwangju
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Jinju
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Seocho Gu
Korea, Republic of	Novartis Investigative Site	Wonju	Gangwon-Do
Korea, Republic of	Novartis Investigative Site	Yangsan Si	Gyeongsangnam Do
Latvia	Novartis Investigative Site	Daugavpils
Latvia	Novartis Investigative Site	Kuldiga
Latvia	Novartis Investigative Site	Liepaja	LV
Latvia	Novartis Investigative Site	Riga	LV
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Valmiera
Lithuania	Novartis Investigative Site	Kaunas	Kauno Apskritis
Lithuania	Novartis Investigative Site	Kaunas	Kauno Apskritis
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Klaipeda	Klaipedos Apskritis
Lithuania	Novartis Investigative Site	Panevezys
Lithuania	Novartis Investigative Site	Siauliai	LTU
Lithuania	Novartis Investigative Site	Siauliai	Siauliu Apskritis
Lithuania	Novartis Investigative Site	Vilnius
Malaysia	Novartis Investigative Site	Alor Setar	Kedah
Malaysia	Novartis Investigative Site	Ipoh	Perak
Malaysia	Novartis Investigative Site	Kuala Lumpur	Selangor Darul Ehsan
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Kuala Lumpur	MYS
Malaysia	Novartis Investigative Site	Kuantan	Pahang
Mauritius	Novartis Investigative Site	Phoenix
Mauritius	Novartis Investigative Site	Solferino Phoenix
Mexico	Novartis Investigative Site	Acapulco
Mexico	Novartis Investigative Site	Aguascalientes
Mexico	Novartis Investigative Site	Chihuahua
Mexico	Novartis Investigative Site	Ciudad de Mexico	Distrito Federal
Mexico	Novartis Investigative Site	Durango
Mexico	Novartis Investigative Site	Guadalajara
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Merida	Yucatan
Mexico	Novartis Investigative Site	Monterrey	Nuevo Leon
Mexico	Novartis Investigative Site	Tlalnepantla	Edo De Mexico
Mexico	Novartis Investigative Site	Xalapa
Mexico	Novartis Investigative Site	Xalapa
Netherlands	Novartis Investigative Site	Alkmaar
Netherlands	Novartis Investigative Site	Amersfoort
Netherlands	Novartis Investigative Site	Amstelveen
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Breda
Netherlands	Novartis Investigative Site	Deventer
Netherlands	Novartis Investigative Site	Doetinchem
Netherlands	Novartis Investigative Site	Gouda
Netherlands	Novartis Investigative Site	Groningen
Netherlands	Novartis Investigative Site	Groningen
Netherlands	Novartis Investigative Site	Heemstede
Netherlands	Novartis Investigative Site	Leeuwarden
Netherlands	Novartis Investigative Site	Leiden
Netherlands	Novartis Investigative Site	Leiderdorp
Netherlands	Novartis Investigative Site	Meibergdreef 9
Netherlands	Novartis Investigative Site	Meppel
Netherlands	Novartis Investigative Site	Nijmegen
Netherlands	Novartis Investigative Site	Nijmegen
Netherlands	Novartis Investigative Site	Sneek	The Netherlands
Netherlands	Novartis Investigative Site	Tiel
Netherlands	Novartis Investigative Site	Tilburg
Netherlands	Novartis Investigative Site	Venlo
New Zealand	Novartis Investigative Site	Auckland
New Zealand	Novartis Investigative Site	Christchurch
New Zealand	Novartis Investigative Site	Christchurch	Canterbury
New Zealand	Novartis Investigative Site	Dunedin	NZW
New Zealand	Novartis Investigative Site	Grafton	Auckland
New Zealand	Novartis Investigative Site	Hamilton
New Zealand	Novartis Investigative Site	Lower Hutt
Norway	Novartis Investigative Site	Arendal
Norway	Novartis Investigative Site	Drammen
Norway	Novartis Investigative Site	Nordbyhagen	Oslo
Norway	Novartis Investigative Site	Oslo
Norway	Novartis Investigative Site	Oslo
Norway	Novartis Investigative Site	Skedsmokorset
Norway	Novartis Investigative Site	Stavanger
Norway	Novartis Investigative Site	Tromsoe
Philippines	Novartis Investigative Site	Iloilo
Philippines	Novartis Investigative Site	Quezon
Philippines	Novartis Investigative Site	San Fernando City	Pampanga
Philippines	Novartis Investigative Site	San Juan City
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Bydgoszcz
Poland	Novartis Investigative Site	Gdynia
Poland	Novartis Investigative Site	Kielce
Poland	Novartis Investigative Site	Klodzko
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Lublin
Poland	Novartis Investigative Site	Nowy Targ	Malopolskie
Poland	Novartis Investigative Site	Olsztyn
Poland	Novartis Investigative Site	Ostroleka	Mazowieckie
Poland	Novartis Investigative Site	Ostrowiec Swietokrzyski
Poland	Novartis Investigative Site	Pulawy
Poland	Novartis Investigative Site	Ruda Slaska
Poland	Novartis Investigative Site	Skierniewice
Poland	Novartis Investigative Site	Sosnowiec	Slaskie
Poland	Novartis Investigative Site	Torun
Poland	Novartis Investigative Site	Torun
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Wloclawek
Poland	Novartis Investigative Site	Zamosc
Portugal	Novartis Investigative Site	Alcabideche
Portugal	Novartis Investigative Site	Almada
Portugal	Novartis Investigative Site	Carnaxide	Lisboa
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Guimaraes
Portugal	Novartis Investigative Site	Leiria
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Matosinhos
Portugal	Novartis Investigative Site	Santa Maria da Feira
Portugal	Novartis Investigative Site	Vila Nova De Gaia
Portugal	Novartis Investigative Site	Vila Real
Puerto Rico	Advanced Clinical Research LLC .	Bayamon
Puerto Rico	Research and Cardiovascular Corp	Ponce
Puerto Rico	Advanced Medical Research Center .	San Juan
Puerto Rico	Barbara Diaz Hernandez Research Inc	San Juan
Puerto Rico	Latin Clinical Trial Center Inc	San Juan
Puerto Rico	Latin Clinical Trial Center Inc Research	San Juan
Romania	Novartis Investigative Site	Baia Mare
Romania	Novartis Investigative Site	Braila	ROM
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Caracal
Romania	Novartis Investigative Site	Craiova
Romania	Novartis Investigative Site	Iasi
Romania	Novartis Investigative Site	Oradea	Jud Bihor
Romania	Novartis Investigative Site	Pitesti	Arges
Romania	Novartis Investigative Site	Targu Mures	Mures
Romania	Novartis Investigative Site	Targu Mures
Romania	Novartis Investigative Site	Timisoara
Romania	Novartis Investigative Site	Timisoara
Romania	Novartis Investigative Site	Timisoara	Timis
Romania	Novartis Investigative Site	Timisoara	Timis
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Ryazan
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	Yaroslavl
Serbia	Novartis Investigative Site	Belgrade
Serbia	Novartis Investigative Site	Belgrade
Serbia	Novartis Investigative Site	Belgrade
Serbia	Novartis Investigative Site	Belgrade
Serbia	Novartis Investigative Site	Cuprija
Serbia	Novartis Investigative Site	Kragujevac
Serbia	Novartis Investigative Site	Leskovac
Serbia	Novartis Investigative Site	Nis
Serbia	Novartis Investigative Site	Smederevo
Serbia	Novartis Investigative Site	Sremska Kamenica
Serbia	Novartis Investigative Site	Subotica
Serbia	Novartis Investigative Site	Vranje
Serbia	Novartis Investigative Site	Zajecar
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Banska Bystrica	SVK
Slovakia	Novartis Investigative Site	Bardejov
Slovakia	Novartis Investigative Site	Bardejov
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava	Slovak Republic
Slovakia	Novartis Investigative Site	Bratislava	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Lucenec
Slovakia	Novartis Investigative Site	Moldava nad Bodvou
Slovakia	Novartis Investigative Site	Nitra
Slovakia	Novartis Investigative Site	Nitra	Slovak Republic
Slovakia	Novartis Investigative Site	Nove Zamky
Slovakia	Novartis Investigative Site	Piestany
Slovakia	Novartis Investigative Site	Povazska Bystrica
Slovakia	Novartis Investigative Site	Presov
Slovakia	Novartis Investigative Site	Roznava
Slovakia	Novartis Investigative Site	Zilina	Zilinsky Kraj
Slovenia	Novartis Investigative Site	Celje
Slovenia	Novartis Investigative Site	Ljubljana
Slovenia	Novartis Investigative Site	Ptuj
Slovenia	Novartis Investigative Site	Slovenj Gradec
South Africa	Novartis Investigative Site	Bloemfontein
South Africa	Novartis Investigative Site	Bloemfontein	Free State
South Africa	Novartis Investigative Site	Cape Town	Western Cape
South Africa	Novartis Investigative Site	Cape Town	Western Cape
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town	ZAF
South Africa	Novartis Investigative Site	George	Western Cape
South Africa	Novartis Investigative Site	Germiston	Gauteng
South Africa	Novartis Investigative Site	Midrand
South Africa	Novartis Investigative Site	Paarl	Western Cape
South Africa	Novartis Investigative Site	Pretoria	Gauteng
South Africa	Novartis Investigative Site	Pretoria	Gauteng
South Africa	Novartis Investigative Site	Pretoria
South Africa	Novartis Investigative Site	Raslouw	Centurion
South Africa	Novartis Investigative Site	Soweto	Gauteng
South Africa	Novartis Investigative Site	Vereeniging	Gauteng
South Africa	Novartis Investigative Site	Worcester
Spain	Novartis Investigative Site	A Coruna
Spain	Novartis Investigative Site	A Coruna	Galicia
Spain	Novartis Investigative Site	Alcorcon	Madrid
Spain	Novartis Investigative Site	Alicante
Spain	Novartis Investigative Site	Almeria	Andalucia
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona	Cataluna
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	El Palmar	Murcia
Spain	Novartis Investigative Site	El Prat de Llobregat	Barcelona
Spain	Novartis Investigative Site	Ferrol	A Coruna
Spain	Novartis Investigative Site	Granada
Spain	Novartis Investigative Site	Hospitalet de Llobregat	Barcelona
Spain	Novartis Investigative Site	Huelva
Spain	Novartis Investigative Site	Jerez	Cadiz
Spain	Novartis Investigative Site	La Coruna	Galicia
Spain	Novartis Investigative Site	Las Palmas de Gran Canaria
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Mallorca	Islas Baleares
Spain	Novartis Investigative Site	Palma De Mallorca	Islas Baleares
Spain	Novartis Investigative Site	Reus	Cataluna
Spain	Novartis Investigative Site	Sabadell	Barcelona
Spain	Novartis Investigative Site	Salamanca	Castilla Y Leon
Spain	Novartis Investigative Site	Salamanca
Spain	Novartis Investigative Site	San Sebastian de los Reyes	Madrid
Spain	Novartis Investigative Site	Sant Joan Despi	Barcelona
Spain	Novartis Investigative Site	Santander	Cantabria
Spain	Novartis Investigative Site	Santiago De Compostela	Galicia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Utrera	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valladolid	Castilla Y Leon
Spain	Novartis Investigative Site	Vigo	Pontevedra
Spain	Novartis Investigative Site	Villamartin	Cadiz
Spain	Novartis Investigative Site	Zaragoza
Sweden	Novartis Investigative Site	Falun
Sweden	Novartis Investigative Site	Goteborg
Sweden	Novartis Investigative Site	Goteborg	Vastra Gotalands Lan
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Malmo
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Stockholm	SE
Sweden	Novartis Investigative Site	Vasteras
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Tainan
Taiwan	Novartis Investigative Site	Tainan
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chiang Mai
Thailand	Novartis Investigative Site	Hat Yai	Songkla
Thailand	Novartis Investigative Site	Muang
Thailand	Novartis Investigative Site	Muang
Turkey	Novartis Investigative Site	Adana
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Bursa
Turkey	Novartis Investigative Site	Cerrahpasa/Istanbul
Turkey	Novartis Investigative Site	Diskapi Ankara
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul	TUR
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Konya
United States	Jefferson Abington	Abington	Pennsylvania
United States	Biofortis Research .	Addison	Illinois
United States	Akron Hospital Summa Health System Akron Hospital	Akron	Ohio
United States	Albany Medical College Div of Community Endocrinology	Albany	New York
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	Cambridge Medical Trials .	Alexandria	Louisiana
United States	PharmaTex Research LLC .	Amarillo	Texas
United States	Alaska Heart and Vascular	Anchorage	Alaska
United States	Northwest Heart Clinical Rsrch LLC .	Arlington Heights	Illinois
United States	Aurora Denver Cardiology Associates	Aurora	Colorado
United States	Rocky Mountain Regional VA Med Ctr	Aurora	Colorado
United States	Central Cardiology Medical Center	Bakersfield	California
United States	Sinai Ct for Throm Res and Drug Dev	Baltimore	Maryland
United States	Louisiana Cardiology Associates .	Baton Rouge	Louisiana
United States	North Hills Medical Research, Inc .	Bedford	Texas
United States	Metropolitan Cardiovascular Consultants Llc	Beltsville	Maryland
United States	Belzoni Clinical Research	Belzoni	Mississippi
United States	Bend Memorial Clinic	Bend	Oregon
United States	Meridian Clinical Research .	Binghamton	New York
United States	Ascension St Vincent's .	Birmingham	Alabama
United States	Excel Medical Clinical Trials LLC	Boca Raton	Florida
United States	Grace Research LLC .	Bossier City	Louisiana
United States	Beth Israel Deaconess Medical Ce .	Boston	Massachusetts
United States	Tufts Medical Center Main Centre	Boston	Massachusetts
United States	VA Boston Healthcare System Jamaica Plain Division	Boston	Massachusetts
United States	Progressive Clinical Research .	Bountiful	Utah
United States	Cardiovascular and Vein Center of Florida	Bradenton	Florida
United States	Nova Clinical Research LLC .	Bradenton	Florida
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Burke Internal Medi And Research .	Burke	Virginia
United States	Butler Memorial Hospital	Butler	Pennsylvania
United States	Hope Clinical Research .	Canoga Park	California
United States	Medical Univ of South Carolina CTBM100C2407	Charleston	South Carolina
United States	Novant Health Heart and Vascular Institute .	Charlotte	North Carolina
United States	Tryon Medical Partners PLLC	Charlotte	North Carolina
United States	Cedar Crosse Research Ct	Chicago	Illinois
United States	Chicago Clinical Research Inst	Chicago	Illinois
United States	University of Cincinnati .	Cincinnati	Ohio
United States	Velocity Clin Research Springdale	Cincinnati	Ohio
United States	Bay Care Medical Group	Clearwater	Florida
United States	University Hospitals Cleveland Medical Center Univ. Hospitals of Cleveland	Cleveland	Ohio
United States	Columbia Heart Clinic	Columbia	South Carolina
United States	Columbia VA Health Care System	Columbia	South Carolina
United States	Johns Hopkins University	Columbia	Maryland
United States	John Muir Physician Network Clinical Research Center	Concord	California
United States	Bassett Medical Center	Cooperstown	New York
United States	Samaritan Cardiology	Corvallis	Oregon
United States	Cardiovascular Associates Research Main Center	Covington	Louisiana
United States	Louisiana Heart Center Research .	Covington	Louisiana
United States	Avant Research Associates LLC	Crowley	Louisiana
United States	North Texas Endocrine Center .	Dallas	Texas
United States	Research Institute of Dallas PA .	Dallas	Texas
United States	Soltero Cardiovascular Research Ctr	Dallas	Texas
United States	SW Family Medicine Associates	Dallas	Texas
United States	Texas Health Physicians Group .	Dallas	Texas
United States	VA North Texas Health Care System .	Dallas	Texas
United States	Cardiology Research Associates	Daytona Beach	Florida
United States	Hillcrest Medical Research	DeLand	Florida
United States	Henry Ford Hospital .	Detroit	Michigan
United States	St Marys Medical Center	Duluth	Minnesota
United States	David Turbay MD PLLC	El Paso	Texas
United States	Elkhart Cardiology Group	Elkhart	Indiana
United States	Meridian Clinical Research LLC .	Endwell	New York
United States	Horizon Research Group of Opelousas, LLC	Eunice	Louisiana
United States	Eastern Shore Research Group, LLC	Fairhope	Alabama
United States	Javara Research .	Fayetteville	Georgia
United States	Javara Research South Coast Health	Fayetteville	Georgia
United States	AA Medical Research Center	Flint	Michigan
United States	G and L Research LLC	Foley	Alabama
United States	Javara Research .	Forest	Virginia
United States	Anderson Medical Research Main Center	Fort Washington	Maryland
United States	Texas Health Physicians Group	Fort Worth	Texas
United States	Texas Health Physicians Group .	Fort Worth	Texas
United States	ASCADA Research	Fullerton	California
United States	Northeast Georgia Medical Center .	Gainesville	Georgia
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	Javara Inc .	Glenn Dale	Maryland
United States	Altru Health Research Dept.	Grand Forks	North Dakota
United States	Healthy Heart Cardiology	Grand Rapids	Michigan
United States	Cardiovascular Institute South ASC	Gray	Louisiana
United States	Bon Secours Medical Group	Greenville	South Carolina
United States	Prisma Health Upstate .	Greenville	South Carolina
United States	Wellmont CVA Heart Institute	Greenville	Tennessee
United States	d-b-a Greenwich Cardio Assoc .	Greenwich	Connecticut
United States	Cooper University Health Care .	Haddon Heights	New Jersey
United States	Heart Clinic of Hammond	Hammond	Louisiana
United States	Louisiana Heart Center Research .	Hammond	Louisiana
United States	Las Vegas Endocrinology	Henderson	Nevada
United States	Indago Research and Health Ctr Inc	Hialeah	Florida
United States	National Research Institute	Hialeah	Florida
United States	Sister Life Research Inc	Hialeah	Florida
United States	Zenith Clinical Research	Hollywood	Florida
United States	Heart Care Associates, P.C.	Hopewell	Virginia
United States	Houston Methodist Hospital .	Houston	Texas
United States	Orion Medical	Houston	Texas
United States	UT Physicians Memorial Hermann	Houston	Texas
United States	Village Medical Village MD S Tx	Houston	Texas
United States	Diabetes Lipid Management Center	Huntington Beach	California
United States	Franciscan Health Services Research Center .	Indianapolis	Indiana
United States	University of Calif Irvine Med Cntr	Irvine	California
United States	Apex Cardiology Research Associates of Jackson	Jackson	Tennessee
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	The Jackson Clinic PA Research	Jackson	Tennessee
United States	VAMC Research-G V Sonny Montgomery Clinic	Jackson	Mississippi
United States	University of Florida -Jacksonville UF Health Jacksonville	Jacksonville	Florida
United States	Westside Center for Clinical Research .	Jacksonville	Florida
United States	Baptist Heart Specialists	Jacksonville Beach	Florida
United States	Gateway Cardiology PC .	Jerseyville	Illinois
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	University of Kansas Medical Center .	Kansas City	Kansas
United States	Kettering Medical Center	Kettering	Ohio
United States	Accellacare .	Knoxville	Tennessee
United States	Turkey Creek Medical Center .	Knoxville	Tennessee
United States	UC San Diego Health Altman Clin Trnsltnl Res Inst	La Jolla	California
United States	Trident Cardiology	Ladson	South Carolina
United States	CV Ins of the South	Lafayette	Louisiana
United States	United Vein and Vascular Centers	Lake Worth	Florida
United States	FMC Science Research	Lampasas	Texas
United States	Capitol Cardiology Associates	Lanham	Maryland
United States	McLaren Greater Lansing	Lansing	Michigan
United States	AB Clinical Trials	Las Vegas	Nevada
United States	Clinical Research of South Nevada .	Las Vegas	Nevada
United States	Witham Health Services .	Lebanon	Indiana
United States	University of Kentucky College of Health Sciences .	Lexington	Kentucky
United States	Physician Research Collaboration .	Lincoln	Nebraska
United States	New Jersey Heart	Linden	New Jersey
United States	ARcare Center for Clinical Research	Little Rock	Arkansas
United States	ARcare Center for Clinical Research .	Little Rock	Arkansas
United States	Arkansas Clinical Research	Little Rock	Arkansas
United States	East Texas Research Associates Inc.	Livingston	Texas
United States	American Institute of Research	Los Angeles	California
United States	Keck Medical Center USC Keck School of Medicine of USC	Los Angeles	California
United States	University Of California LA	Los Angeles	California
United States	U of Louisville Rudd Heart and Lung .	Louisville	Kentucky
United States	Garden State Heart Care	Manalapan	New Jersey
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Clinical Trials Management, LLC .	Mandeville	Louisiana
United States	North Shore Heart and Vascular	Mandeville	Louisiana
United States	Rama Research, LLC	Marion	Ohio
United States	CardioVoyage LLC Abo Auda Associates	McKinney	Texas
United States	Memphis Cardiology and Vein Ct	Memphis	Tennessee
United States	Solaris Clinical Research	Meridian	Idaho
United States	The Heart Center of Lake County	Merrillville	Indiana
United States	Cardiovascular Associates of Mesa	Mesa	Arizona
United States	Omega Clinical Research	Metairie	Louisiana
United States	ActivMed Practices and Research	Methuen	Massachusetts
United States	A&A Research Group Inc	Miami	Florida
United States	Infinite Clinical Research	Miami	Florida
United States	Inpatient Research Clinical LLC	Miami Lakes	Florida
United States	RM Medical Research Inc	Miami Lakes	Florida
United States	MyMichigan Medical Center Midland Main Center	Midland	Michigan
United States	NYU Langone Hlth Card Assoc	Mineola	New York
United States	University of Minnesota .	Minneapolis	Minnesota
United States	Eminat LLC	Miramar	Florida
United States	Clinical Trials of America LA LLC	Monroe	Louisiana
United States	Lucas Research .	Morehead City	North Carolina
United States	Cardiovascular Rea Of NW Ind, LlC	Munster	Indiana
United States	Novartis Investigative Site	Myrtle Beach	South Carolina
United States	Saltzer Health	Nampa	Idaho
United States	Advanced Research for Health Improvement LLC .	Naples	Florida
United States	Barnum Medical Research Inc .	Natchitoches	Louisiana
United States	Robert Wood Johnson Medical School .	New Brunswick	New Jersey
United States	Crescent City Physicians Inc .	New Orleans	Louisiana
United States	Icahn School of Med at Mt Sinai	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	York Clinical Research Clinical Research	Norfolk	Virginia
United States	North Kansas City Hospital	North Kansas City	Missouri
United States	Northport VA Medical Center	Northport	New York
United States	Ocala Cardiovascular Research	Ocala	Florida
United States	CCT Research Research	Omaha	Nebraska
United States	VA Medical Center - NWI, Endocrine Studies (R151) Western Iowa Hlth Care Sys	Omaha	Nebraska
United States	CV Ins of the South .	Opelousas	Louisiana
United States	Midwest Heart and Vascular Spec	Overland Park	Kansas
United States	Oviedo Medical Research	Oviedo	Florida
United States	MD Medical Research	Oxon Hill	Maryland
United States	CTMD Research	Palm Springs	Florida
United States	VA Palo Alto Health Care System .	Palo Alto	California
United States	Alta Pharmaceutical Research Center	Peachtree Corners	Georgia
United States	Broward Research Center	Pembroke Pines	Florida
United States	SEC Clinical Research	Pensacola	Florida
United States	Methodist Med Center Of Illinois	Peoria	Illinois
United States	Discovery Clinical Trials .	Pflugerville	Texas
United States	Elite Clinical Studies .	Phoenix	Arizona
United States	Preferred Primary Care Physicians	Pittsburgh	Pennsylvania
United States	Preferred Primary Care Physicians Main Center	Pittsburgh	Pennsylvania
United States	UPMC .	Pittsburgh	Pennsylvania
United States	Heartplace-Plano Main Center	Plano	Texas
United States	Minnesota Center Multiple Sclerosis Drug Shipment	Plymouth	Minnesota
United States	Peace River Cardiovascular Center	Port Charlotte	Florida
United States	Cardiovascular Res of Knoxville LLC .	Powell	Tennessee
United States	NC Heart and Vascular Research LLC	Raleigh	North Carolina
United States	Dominion Medical Associates	Richmond	Virginia
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Roanoke Heart Institute	Roanoke	Virginia
United States	North Memorial Heart and Vascular Institute	Robbinsdale	Minnesota
United States	Rochester Clinical Research	Rochester	New York
United States	Adventist HealthCare Shady Grove Medical Center	Rockville	Maryland
United States	Ascension St Mary s Hospital	Saginaw	Michigan
United States	CentraCare Heart and Vascular Ctr	Saint Cloud	Minnesota
United States	Gateway Cardiovascular Rsch Ctr Inc	Saint Louis	Missouri
United States	Mercy South .	Saint Louis	Missouri
United States	St Louis Heart and Vascular .	Saint Louis	Missouri
United States	St Louis V A Medical Center .	Saint Louis	Missouri
United States	Regions Hospital Main Center	Saint Paul	Minnesota
United States	Advanced Medical Research Center .	Saint Petersburg	Florida
United States	Accellacare	Salisbury	North Carolina
United States	Tidal Health Peninsula Regional Inc .	Salisbury	Maryland
United States	Endeavor Clinical Trials .	San Antonio	Texas
United States	Sou Tx Cardiovascular Consu PLLC .	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio .	San Antonio	Texas
United States	San Diego Veterans Medical Center	San Diego	California
United States	West Coast Research LLC .	San Ramon	California
United States	Helping Hands Medical Associates INC	Santa Ana	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	HonorHealth Heart Group Deer Valley .	Scottsdale	Arizona
United States	Swedish Medical Ctr Cardiovascular Re	Seattle	Washington
United States	University of Washington Clin Atherosclerosis Res Lab	Seattle	Washington
United States	Virginia Mason Medical Centre	Seattle	Washington
United States	Sherman Clinical Research .	Sherman	Texas
United States	Grace Research Llc .	Shreveport	Louisiana
United States	North Central Heart .	Sioux Falls	South Dakota
United States	Sanford University of South Dakota Medical Center Sanford Cardiovascular Institu	Sioux Falls	South Dakota
United States	Louisiana Heart Center Research .	Slidell	Louisiana
United States	Frontier Clinical Research LLC	Smithfield	Pennsylvania
United States	Cardio Metabolic Institute CACZ885M2301	Somerset	New Jersey
United States	Providence Hospital Patient Care Research	Southfield	Michigan
United States	Encompass Clinical Research .	Spring Valley	California
United States	Heart House Research Foundation	Springfield	Ohio
United States	Mercy Hospital .	Springfield	Missouri
United States	Prairie Heart Institute	Springfield	Illinois
United States	SIU School of Medicine	Springfield	Illinois
United States	Stanford University Medical Center School of Medicine	Stanford	California
United States	Javara Research	Stephenville	Texas
United States	Manshadi Heart Institute	Stockton	California
United States	State Uni of NY at Stony Brook	Stony Brook	New York
United States	Privia Medical Group Gulf Coast	Sugar Land	Texas
United States	Clinical Research Inst of Arizona	Sun City West	Arizona
United States	Universal Research Group LLC Suite 202	Tacoma	Washington
United States	BayCare Health System .	Tampa	Florida
United States	BayCare Medical Group Inc	Tampa	Florida
United States	Genesis Clinical Research .	Tampa	Florida
United States	James A Haley Veterans Hospital .	Tampa	Florida
United States	New Tampa Health	Tampa	Florida
United States	Ravessa Clinical Research	Tampa	Florida
United States	Alina clinical trials .	Texas City	Texas
United States	Alina clinical trials Baxter REsearch LLC	Texas City	Texas
United States	Javara Research	The Woodlands	Texas
United States	Novartis Investigative Site	The Woodlands	Texas
United States	Mercy Health St Vincent Med Ctr	Toledo	Ohio
United States	Cotton-O Neil Clinical Res Center	Topeka	Kansas
United States	Uni of California at Los Angeles	Torrance	California
United States	Traverse Heart and Vascular .	Traverse City	Michigan
United States	Atlanta Heart Specialists LLC Main Center	Tucker	Georgia
United States	Pima Heart And Vascular Clin Rch .	Tucson	Arizona
United States	Tennessee Center For Clinical Trials	Tullahoma	Tennessee
United States	Oklahoma Heart Institute .	Tulsa	Oklahoma
United States	Cardiology Associates of North MS .	Tupelo	Mississippi
United States	Tilda Research	Tustin	California
United States	Westchester Medical Center .	Valhalla	New York
United States	Premier Cardiovascular Institute	Vandalia	Ohio
United States	Blue Coast Research Center LLC .	Vista	California
United States	Kent County Memorial Hospital .	Warwick	Rhode Island
United States	Emerson Clinical Research Institute .	Washington	District of Columbia
United States	Chase Medical Research LLC	Waterbury	Connecticut
United States	Covenant Medical Center MercyOne Waterloo Med Ct	Waterloo	Iowa
United States	Cardiology Partners Clinical Research Institute	Wellington	Florida
United States	Cardiology Partners Clinical Research Institute Suite 206	Wellington	Florida
United States	Confluence Health Hospital	Wenatchee	Washington
United States	Interv Cardiology Med Grp	West Hills	California
United States	Ascension Via Christi Research .	Wichita	Kansas
United States	Winchester Medical Center	Winchester	Virginia
United States	Wake Forest U of Health Sciences Cardiology Dept	Winston-Salem	North Carolina
United States	Wake Forest Uni Baptist MC StudyCoordinator	Winston-Salem	North Carolina
United States	Yazoo Clinical Research .	Yazoo City	Mississippi
United States	Trinity Health Michigan Heart .	Ypsilanti	Michigan
United States	Southern Clinical Research	Zachary	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Denmark,  Estonia,  Finland,  France,  Greece,  Hungary,  Iceland,  India,  Israel,  Italy,  Japan,  Kenya,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mauritius,  Mexico,  Netherlands,  New Zealand,  Norway,  Philippines,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events)	3P-MACE is a confirmed composite endpoint which includes cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke.	From randomization to total follow-up time (up to 72 months)
Secondary	Time to Occurrence of Cardiovascular (CV) Death	CV death is defined as death due to cardiovascular events	From randomization to total follow-up time (up to 72 months)
Secondary	Time to First Occurrence of 4P-MACE (4-Point Major Adverse Cardiovascular Events)	A composite 4P- MACE is defined as CV death, non-fatal MI, non-fatal ischemic stroke and urgent coronary revascularization.	From randomization to total follow-up time (up to 72 months)
Secondary	Time to first occurrence of Major Limb Adverse Events (MALE)	Major Limb Adverse Events including acute lower limb ischemia, lower limb amputation due to ischemia, or urgent lower limb revascularization for ischemia	From randomization to total follow-up time (up to 72 months)
Secondary	Time to occurrence of all-cause death	All-Cause death is defined as: all deaths from randomization until up to 72 months	From randomization to total follow-up time (up to 72 months)