ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

Cardiovascular Risk Clinical Trial

— ARTEMIS  

Official title:

ARTEMIS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06118281
• Other study ID #: EX6018-4979
• Secondary ID: U1111-1294-34732
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 25, 2024
• Est. completion date: September 3, 2026

Study information

• Verified date: March 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: September 3, 2026
• Est. primary completion date: September 3, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or above at the time of signing the informed consent

• Hospitalisation for acute myocardial infarction with evidence of type 1 MI (myocardial infarction) by invasive angiography performed at site with percutaneous coronary intervention (PCI) capabilities

• ST-segment elevation myocardial infarction (STEMI) with all the following: a) Relevant symptoms suggestive of cardiac ischaemia within 12 hours before hospitalisation or during hospitalisation, b) Electrocardiogram (ECG)-changes (in the absence of left ventricular hypertrophy or left bundle branch block): ST-segment elevation at the J point in at least two contiguous leads greater than or equal to 0.25 millivolt (mV) in men less than 40 years, greater than or equal to 0.2 mV in men greater than or equal to 40 years, or greater than or equal to 0.15 mV in women in leads V2-V3; and/or greater than or equal to 0.1 mV in all other leads OR - Non-ST-segment myocardial infarction (NSTEMI) with all the following: a) Relevant symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation or during hospitalisation, b) Rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit

• Possibility for randomisation as early as possible after invasive procedure, and latest within 36 hours of hospitalisation (time 0) for STEMI, and latest within 48 hours of hospitalisation (time 0) for NSTEMI

• Presence of at least one of the following criteria (confirmed based on the participant's medical records and/or medical history interview): a) Any prior MI b) Prior coronary revascularisation, c) Diabetes mellitus treated with glucose-lowering agent(s), d) Known chronic kidney disease (CKD) (estimated glomerular filtration rate (eGFR) greater than equal to 15 and less than 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2), e) Prior ischaemic stroke, f) Known carotid disease or peripheral artery disease in the lower extremities, g) Multivessel coronary artery disease (current/prior), h) For STEMI participants only: anterior MI at index AMI

Exclusion Criteria:

• Use of fibrinolytic therapy for treatment of the current AMI (acute myocardial infarction)

• Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV

• Ongoing haemodynamic instability defined as any of the following: a) Killip Class III or IV, b) Sustained and/or symptomatic hypotension (systolic blood pressure less than 90 millimeters of mercury (mmHg))

• Severe kidney impairment defined as any of the following: Chronic haemodialysis or peritoneal dialysis

• Known alanine aminotransferase (ALT) greater than 8 x upper limit of normal (reference range) (ULN)

• Severe hepatic disease defined as at least one of the following: a) Previously known or current hepatic encephalopathy (clinical evaluation), b) Previously known or current ascites (clinical evaluation), c) Jaundice (clinical evaluation), d) Previous oesophageal/gastric variceal bleeding, e) Known hepatic cirrhosis

• Major cardiac surgical (including but not restricted to coronary artery bypass graft surgery [CABG]), non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days or any major surgical procedure planned at the time of randomisation or as treatment for the current AMI (CABG). Deferred (staged) percutaneous coronary intervention for a non-culprit vessel identified during the current AMI is allowed

• Clinical evidence of, or suspicion of, active infection at the discretion of the investigator

• Known (acute or chronic) hepatitis B or hepatitis C

• History or evidence of untreated latent tuberculosis (TB) such as (but not limited to): a) History of a positive TB test or chest X-ray compatible with latent TB; and TB treatment initiated less than 28 days prior to randomisation, b) Participants with TB risk factors but unwilling to undergo TB treatment if confirmed positive for latent TB based on central laboratory test at baseline (visit 2)

Related Conditions & MeSH terms

• Acute Myocardial Infarction (AMI)
• Cardiovascular Risk
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Ziltivekimab
Ziltivekimab will be adminsitered subcutaneously as an initial loading dose of Dose 1 followed by a maintenance dose of Dose 2 once- monthly.
• Placebo
Placebo matched to ziltivekimab will be adminsitered subcutaneously as an initial loading dose followed by a maintenance dose once-monthly.

Locations

Country	Name	City	State
Argentina	Hospital Italiano	Buenos Aires
Argentina	Sanatorio Finochietto	Buenos Aires
Argentina	Fundacion Favaloro	Caba
Argentina	Instituto Cardiovascular Buenos Aires	Caba
Argentina	Sanatorio Güemes	Caba	City Of Buenos Aires
Argentina	Clínica Privada Velez Sarsfield	Córdoba
Argentina	Instituto de Cardiología de Corrientes	Corrientes
Argentina	Hospital Español de Mendoza	Godoy Cruz, Mendoza	Mendoza
Argentina	Hospital Italiano de la Plata	La Plata	Buenos Aires
Argentina	Hospital Universitario Austral	Pilar	Buenos Aires
Argentina	Sanatorio Modelo Quilmes	Quilmes	Buenos Aires
Argentina	Sanatorio Parque	Rosario	Santa Fé
Argentina	Centro Privado de Cardiología	San Miguel De Tucuimán	Tucumán
Argentina	Fundación Nuestra Señora del Rosario - Estudios Clínicos los Arroyos	San Nicolás de los Arroyos	Buenos Aires
Australia	Royal Adelaide Hospital Cardiovascular Clinical Trials	Adelaide	South Australia
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	The Prince Charles Hospital	Brisbane	Queensland
Australia	Cairns Base Hospital	Cairns	Queensland
Australia	Concord Repatriation General Hospital - Cardiology	Concord	New South Wales
Australia	Northern Health	Epping	Victoria
Australia	Frankston Hospital	Frankston	Victoria
Australia	Barwon Health (The Geelong Hospital)	Geelong	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	The Alfred Hospital	South Yarra	Victoria
Australia	Gold Coast University Hosptial	Southport	Queensland
Australia	Sunshine Hospital	St Albans	Victoria
Australia	Illawarra Heart Health Centre	Wollongong	New South Wales
Brazil	Jmf Clínica Do Coração Ltda	Aracaju
Brazil	NUPEC Cardio	Belo Horizonte	Minas Gerais
Brazil	Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista	Bragança Paulista	São Paulo
Brazil	Hospital do Coração do Brasil	Brasilia	Distrito Federal
Brazil	Instituto de Pesquisa Clínica de Campinas	Campinas	Sao Paulo
Brazil	PUCCAMP - Hospital e Maternidade Celso Pierro	Campinas	Sao Paulo
Brazil	Integral Pesquisa e Ensino	Cidade Nova Votuporanga	São Paulo
Brazil	Hospital Ruy Azeredo Ltda	Goiânia	Goiás
Brazil	Irmandade da Santa Casa de Misericórdia de Marília	Marília	São Paulo
Brazil	Hospital Israelita Albert Einstein	Morumbi	Sao Paulo
Brazil	Irmandade Santa Casa de Misericórdia de Passos	Passos	Minas Gerais
Brazil	Hospital Maternidade e Pronto Socorro Santa Lúcia	Poços de Caldas	Minas Gerais
Brazil	Hospital São Lucas - PUC/RS	Porto Alegre	Rio Grande Do Sul
Brazil	Irmandade da Santa Casa de Misericordia de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Mãe de Deus - Porto Alegre	Porto Alegre/RS
Brazil	ASSOCIAÇÃO LAR SÃO FRANCISCO DE ASSIS NA PROVIDÊNCIA DE DEUS - Hospital Regional de Presidente Prudente	Presidente Prudente	São Paulo
Brazil	Hospital Agamenon Magalhães	Recife	Pernambuco
Brazil	CIP Centro Integrado de Pesquisas do Hospital de Base	São José do Rio Preto	Sao Paulo
Brazil	Hospital das Clínicas da Universidade Federal do Triangulo Mineiro	Uberaba	Minas Gerais
Brazil	Centro de Pesquisa Clínica do Hospital de Clínicas da Universidade Federal de Uberlândia	Uberlândia	Minas Gerais
Bulgaria	MHAT "Puls" AD Cardiology Department	Blagoevgrad
Bulgaria	"UMHAT-Burgas"	Burgas
Bulgaria	MHAT Hearth and brain EAD	Burgas
Bulgaria	UMHAT "Deva Maria" EOOD	Burgas
Bulgaria	Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD	Gabrovo
Bulgaria	Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD	Gotse Delchev
Bulgaria	MHAT Haskovo AD	Haskovo
Bulgaria	MHAT - Dr. Atanas Dafovski AD	Kirdzhali
Bulgaria	Multidisciplinary Hospital For Active Treatment Cardiolife Ltd.	Lovech
Bulgaria	Multi-Profile Hospital For Active Treatment - City Clinic - Sveti Georgi EOOD	Montana
Bulgaria	"MHAT - Pazardzhik"	Pazardzhik
Bulgaria	UMHAT Heart and Brain	Pleven
Bulgaria	"UMHAT "Sveti Georgi" EAD	Plovdiv
Bulgaria	'MHAT Sveta Karidad' EAD	Plovdiv
Bulgaria	MHAT MC-Sv Ivan Rilski EOOD	Plovdiv
Bulgaria	UMHAT Pulmed	Plovdiv
Bulgaria	Specialized Hospital For Active Cardiology Treatment Medica Kor EAD	Ruse
Bulgaria	MHAT Southwest Hospital OOD	Sandanski
Bulgaria	'MHAT Hadzhi Dimitar' OOD	Sliven
Bulgaria	MHAT "Dr. Bratan Shukerov"	Smolyan
Bulgaria	"Acibadem City Clinic MHAT Tokuda" EAD,Cardiology department	Sofia
Bulgaria	"Acibadem City Clinic UMHAT" EOOD, Sofia, Cardiology clinic	Sofia
Bulgaria	"MHAT "NCH" EAD, Clinic of Cardiology, Depart. of Cardiology	Sofia
Bulgaria	"UMHAT "Aleksandrovska" EAD, Cardiology clinic	Sofia
Bulgaria	"UMHAT "Sveta Anna" Sofia" AD, Clinic of Cardiology	Sofia
Bulgaria	"UMHATEM N.I. Pirogov" EAD	Sofia
Bulgaria	University Multidisciplinary Hospital for Active Treatment Sveta Ekaterina EAD	Sofia
Bulgaria	Specialized Hospital For Active Cardiology Treatement Cardiolife OOD	Varna
Bulgaria	UMHAT "Sveta Marina" EAD	Varna
Bulgaria	Specialized Hospital for Active Treatment of Cardiology - Yambol EAD	Yambol
Canada	William Osler Health System-Brampton Civic Hospital	Brampton	Ontario
Canada	Heritage Medical Research Clinic	Calgary	Alberta
Canada	Grey Nuns Community Hospital	Edmonton	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital_Edmonton	Edmonton	Alberta
Canada	QE II Health Sciences Centre	Halifax	Nova Scotia
Canada	Kelowna Cardiology Research Ltd.	Kelowna	British Columbia
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Center Ontario	London	Ontario
Canada	Hopital Sacre-Coeur de Montreal	Montréal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	University of Ottawa Heart Ins	Ottawa	Ontario
Canada	CHU de Quebec-Universite-Laval,HDQ	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Niagara Health System - New St. Catherines Site	St. Catharines	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	The Second Affiliated Hospital Of Chongqing Medical University	Chongqing	Chongqing
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Nanfang Hospital, Southern Medical University	Guangzhou
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Hospital, Zhejiang University School of Medicine	Hangzhou
China	The First Affliated Hospital of Harbin Medical University	Harbin
China	Jinan Central Hospital	Ji'nan	Shandong
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Zhongda Hospital, Southeast University	Nanjing
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing City,	Jiangsu
China	Zhongshan Hospital,Fudan University	Shanghai
China	The People's Hospital of Liaoning Province	Shenyang	Liaoning
China	General Hospital of Tianjin Medical University	Tianjin	Tianjin
China	TEDA International Cardiovascular Hospital	Tianjin	Tianjin
China	Tianjin People's Hospital	Tianjin
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an
Czechia	Fakultni nemocnice Brno	Brno
Czechia	FN u Sv. Anny	Brno
Czechia	Nemocnice Ceske Budejovice	Ceske Budejovice
Czechia	Krajská nemocice Liberec, a.s	Liberec	Czech Republic
Czechia	Nemocnice Pardubickeho kraje a.s., Pardubicka nemocnice	Pardubice
Czechia	Fakultni nemocnice Plzen	Plzen - Bory
Czechia	Nemocnice na Homolce	Prague
Czechia	IKEM	Praha
Czechia	Fakultní nemocnice Královské Vinohrady	Praha 10
Czechia	II. interni klinika VFN - Kardiologie a angiologie	Praha 2
Czechia	Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.	Ústní Nad Labem
Denmark	Aalborg Universitetshospital Kardiologisk Afdeling	Aalborg
Denmark	Aarhus Universitetshospital, Skejby Hjertesygdomme	Aarhus N
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev og Gentofte Hospital	Hellerup	Region Hovedstaden
Denmark	Nordsjællands hospital	Hillerød
Denmark	Kardiologisk afdeling Odense Universitetshospital	Odense C
Denmark	Kardiologisk Odense & Svendborg	Svendborg
France	Centre Hospitalier Universitaire de Besancon-Hopital Jean Minjoz	Besançon Cedex
France	Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre-1	Caen Cedex 9
France	Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau	Chambray Les Tours
France	Centre Hospitalier Sud Francilien	Corbeil Essonnes
France	Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-1	Grenoble cedex 9
France	Les Hopitaux de Chartres-Hopital Louis Pasteur	Le Coudray
France	Centre Hospitalier Universitaire de Lille-Institut Coeur Poumon	Lille
France	Centre Hospitalier Saint Joseph Saint Luc	Lyon
France	Aphp-Hopital La Pitie Salpetriere-1	Paris
France	Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-1	Pessac
France	Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1	Toulouse Cedex 9
France	Chru de Nancy - Hopital Brabois	Vandoeuvre Les Nancy
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	BG Klinikum Unfallkrankenhaus Berlin gGmbH - Klinik für Innere Medizin/Kardiologie	Berlin
Germany	Charité Universitätsmedizin Berlin Campus Benjamin Franklin	Berlin
Germany	Universitätsklinik für Kardiologie und Internistische Intensivmedizin Bielefeld	Bielefeld
Germany	Bremer Institut für Herz- und Kreislaufforschung (BIHKF)	Bremen
Germany	Helios Amper-Klinikum Dachau	Dachau
Germany	Kath. St. Paulus GmbH - St Johannes Hospital gGmbH	Dortmund
Germany	Herzzentrum Dresden GmbH Universitätsklinik	Dresden
Germany	Städtisches Klinikum Dresden - 2. Medizinische Klinik	Dresden
Germany	Universitätsklinikum Düsseldorf - Klinik für Kardiologie, Pneumologie und Angiologie	Düsseldorf
Germany	Helios Klinikum Erfurt	Erfurt
Germany	MVZ CCB Frankfurt Und Main-Taunus GbR	Frankfurt
Germany	Universitätsklinikum Frankfurt aM	Frankfurt am Main
Germany	Medical Center - University Of Freiburg	Freiburg
Germany	Klinikum Friedrichshafen GmbH - Klinik für Kardiologie, Angiologie, Pneumologie und internistische Intensivmedizin	Friedrichshafen
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie	Hannover
Germany	Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie	Heidelberg
Germany	St. Vinzenz-Hospital Köln	Köln
Germany	Asklepios Klinik Langen	Langen
Germany	University of Leipzig	Leipzig
Germany	Medizinische Klinik 1, Klinikum Leverkusen gGmbH	Leverkusen
Germany	Universitätsklinikum Mannheim GmbH I. Medizinische Klinik	Mannheim
Germany	Deutsches Herzzentrum München	München
Germany	Uniklinik Regensburg Innere Medizin II	Regensburg
Germany	Robert-Bosch-Krankenhaus GmbH Stuttgart	Stuttgart
Germany	Universitätsklinikum Tübingen - Innere Medizin III Kardiologie und Angiologie	Tübingen
Greece	General Hospital of Athens "Elpis"	Ampelokipoi/Athens
Greece	"Hygeia" General Hospital of Athens	Athens
Greece	"Sotiria" Thoracic Diseases Hospital of Athens	Athens
Greece	'G. Gennimatas' General Hospital of Athens	Athens
Greece	Alexandra General Hospital, Therapeutic Clinic	Athens
Greece	G.H. of Athens "Evaggelismos"	Athens
Greece	Group Euroclinic - Athens Euroclinic	Athens
Greece	Henry Dunant Hospital Center	Athens
Greece	Hippokration Hospital	Athens
Greece	Konstantopouleio G.H. of Athens, "Agia Olga"	Athens
Greece	Nimits Hospital	Athens
Greece	Asklepieion General Hospital	Athens/Voula
Greece	U.G.H of Athens "Attikon"	Chaidari, Athens
Greece	General Hospital of Chios "Skilitsio"	Chios
Greece	General Hospital of Athens "LAIKO"	Goudi/Athens
Greece	University General Hospital of Ioannina,Internal Medicine	Ioannina
Greece	KAT General Hospital of Attica	Kifissia
Greece	Univ Gen Hospital Larisa, Internal Medicine Clinic	Larissa/Thessaly
Greece	Sismanogleio General Hospital	Marousi
Greece	General Hospital Of Thessaloniki Papageorgiou	Nea Efkarpia	Thessaloniki
Greece	Tzaneio General Hospital of Piraeus	Piraeus
Greece	"AHEPA" University General Hospital of Thessaloniki	Thessaloniki
Greece	Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt	Thessaloniki
India	Marengo CIMS Hospital	Ahmedabad
India	Sardar Vallabhbhai Patel Institute of Medical Sciences and Research	Ahmedabad	Gujarat
India	Jawaharlal Nehru Medical College and Hospital	Aligarh	Uttar Pradesh
India	Ramaiah Memorial Hospital	Bengaluru	Karnataka
India	Sri Jayadeva Institute of Cardiovascular Sciences & Research	Bengaluru	Karnataka
India	All India Institute of Medical Sciences (AIIMS), Bhubaneswar	Bhubaneswar	Odisha
India	S.P. Medical College & Associated Group of Hospitals	Bikaner	Rajasthan
India	Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh	Chandigarh
India	Sri Ramachandra Medical Centre	Chennai	Tamil Nadu
India	The Madras Medical Mission	Chennai	Tamil Nadu
India	G. Kuppuswamy Naidu Memorial Hospital	Coimbatore	Tamil Nadu
India	SCB Medical College and Hospital	Cuttack	Odisha
India	Shri Mahant Indiresh Hospital	Dehradun	Uttarakhand
India	Lalitha Super Specialities Hospital	Guntur	Andhra Pradesh
India	ESIC Medical College and Hospital, Hyderabad	Hyderabad	Telangana
India	Malla Reddy Narayana Multispeciality Hospital	Hyderabad	Telangana
India	Osmania General Hospital	Hyderabad	Telengana
India	SMS Medical College & Attached Hospitals	Jaipur	Rajasthan
India	Ganesh Shankar Vidyarthe Memorial Medical College (GSVM Medical College)	Kanpur	Uttar Pradesh
India	Lisie Hospital	Kochi	Kerala
India	Apollo Multispeciality Hospital, Kolkata	Kolkata	West Bengal
India	B M Birla Heart Research Centre	Kolkata	West Bengal
India	Medical College & Hospital, Kolkata	Kolkata	West Bengal
India	Nil Ratan Sircar Medical College and Hospital	Kolkata	West
India	Dr. Ram Manohar Lohia Institute of Medical Sciences	Lucknow	Uttar Pradesh
India	King George's Medical University (KGMU)	Lucknow	Uttar Pradesh
India	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Lucknow	Uttar Pradesh
India	Dayanand Medical College & Hospital	Ludhiana	Punjab
India	Justice K S Hegde Charitable Hospital	Mangaluru	Karnataka
India	Fortis Hospital, Mohali	Mohali	Punjab
India	Seth GS Medical College & KEM Hospital	Mumbai	Maharashtra
India	All India Institute of Medical Sciences (AIIMS), Nagpur	Nagpur	Maharashtra
India	Arneja Heart & Multispeciality Hospital	Nagpur	Maharashtra
India	Central India Cardiology Hospital and Research Institute	Nagpur	Maharashtra
India	Shri Krishna Hrudayalaya & Critical Care Centre	Nagpur	Maharashtra
India	Chopda Medicare and Research Centre Pvt. Ltd.	Nashik	Maharashtra
India	Vijan Hospital & Research Centre	Nashik	Maharashtra
India	Aakash Healthcare Super Speciality Hospital	New Delhi
India	All India Institute of Medical Sciences (AIIMS)	New Delhi	Delhi
India	Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital	New Delhi	Delhi
India	Batra Hospital and Medical Research Center	New Delhi	Delhi
India	Fortis Escorts Heart Institute, New Delhi	New Delhi	Delhi
India	G B Pant Institute of Postgraduate Medical Education and Research	New Delhi	Delhi
India	Indraprastha Apollo Hospital, New Delhi	New Delhi	Delhi
India	Max Super Speciality Hospital, Saket	New Delhi	Delhi
India	Sir Ganga Ram Hospital	New Delhi	Delhi
India	Vardhaman Mahavir Medical College & Safdarjung Hospital	New Delhi	Delhi
India	Lakshmi Hospital	Palakkad	Kerala
India	Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)	Puducherry
India	Deenanath Mangeshkar Hospital & Research Centre	Pune	Maharashtra
India	Sahyadri Super Speciality Hospital	Pune	Maharashtra
India	SMC Heart Institute and IVF Research Centre	Raipur	Chhattisgarh
India	Shri B. D. Mehta Mahavir Heart Institute	Surat	Gujarat
India	Kasturba Medical College and Hospital, Manipal	Udupi	Karnataka
India	Rhythm Heart Institute	Vadodara	Gujarat
India	Sterling Hospitals, Race Course Road	Vadodara	Gujarat
India	King George Hospital	Visakhapatnam	Andhra Pradesh
India	Medicover Hospitals, Visakhapatnam MVP	Visakhapatnam	Andhra Pradesh
Israel	Cardiology department Hillel Yaffe MC Hadera	Hadera
Israel	Heart failure unit Rambam Medical center	Haifa
Israel	The Heart Institute Wolfson Medical Center, Holon	Holon
Israel	Cardiology department Hadassah Medical Center Mount Scopus	Jerusalem
Israel	Hadassah Ein Kerem MC - Cardio	Jerusalem
Israel	Cardiology department Meir Medical Center Kfar Saba	Kfar Saba
Israel	Cardiac intensive unit Rabin MC	Petah Tikva
Israel	Cardiac Intensive Care Kaplan Medical Center	Rehovot
Israel	Cardio Vascular Research Center Sourasky MC	Tel Aviv
Israel	Sheba Medica Center - Clinical Research Unit	Tel Hashomer
Israel	Shamir (Assaf Harofe) Medical Center	Zrifin
Italy	Ente Ecclesiastico Ospedale Generale Regionale Miulli	Acquaviva delle Fonti
Italy	Ospedale Maggiore Carlo Alberto Pizzardi	Bologna
Italy	AORN "Sant'Anna e San Sebastiano"	Caserta	Ce
Italy	Azienda Ospedaliero-Universitaria Renato Dulbecco	Catanzaro
Italy	Ss. Annunziata	Chieti
Italy	A.O.U. Ferrara, Sant'Anna	Cona (Ferrara)	Fe
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	Ospedale Policlinico San Martino	Genova
Italy	Ospedale Misericordia Grosseto	Grosseto
Italy	Ospedale Sant'Andrea	La Spezia
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	Fondazione IRCCS San Gerardo dei Tintori	Monza
Italy	Azienda Ospedaliera Universitaria Federico II di Napoli	Napoli
Italy	Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara	Novara
Italy	Azienda Ospedaliera di Parma	Parma
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Arcispedale S Maria Nuova Azienda ULSS-IRCCS	Reggio Emilia
Italy	Ospedale Infermi Rimini	Rimini
Italy	Presidio Ospedaliero di Rivoli	Rivoli	To
Italy	Azienda Ospedaliero - Universitaria Sant'Andrea	Rome
Italy	Fatebenefratelli Isola Tiberina Gemelli Isola	Rome
Italy	Ospedale Sandro Pertini	Rome
Italy	Policlinico Casilino	Rome
Italy	IRCCS Policlinico San Donato	San Donato Milanese
Italy	A.O.U Città della Salute e della Scienza di Torino	Torino
Italy	Azienda Sanitaria Ospedaliera Ordine Mauriziano SC Cardiologia	Torino	To
Italy	AOUI Verona	Verona
Japan	Fujita Health University Hospital_Cardiology	Aichi
Japan	Asahi General Hospital_Cardiology	Chiba
Japan	Toho University Sakura Medelical Center_Cardiology	Chiba
Japan	Ehime Prefectural Central Hospital	Ehime
Japan	Matsuyama Red Cross Hospital_Department of Cardiovascular Medicine	Ehime
Japan	Japanese Red Cross Fukuoka Hospital_Cardiology	Fukuoka
Japan	St.Mary's Hospital_Cardiology	Fukuoka
Japan	Fukuoka University Hospital_Cardiology	Fukuoka-shi, Fukuoka
Japan	Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology	Himeji-shi, Hyogo
Japan	Hanaoka Seishu Memorial Hospital	Hokkaido
Japan	Hyogo Medical University Hospital_Cardiovascular Medicine	Hyogo
Japan	Nishinomiya Watanabe Cardiovascular Center_Cardiovascular Medicine	Hyogo
Japan	Mito Saiseikai General Hospital_Cardiology	Ibaraki
Japan	Tsuchiura Kyodo General Hospital_Internal Medicine	Ibaraki
Japan	Ishikawa Prefectural Central Hospital_Cardiology	Ishikawa
Japan	Kanto Rosai Hospital_Cardiology	Kanagawa
Japan	Saiseikai Yokohamashi Tobu Hospital_Cardiology	Kanagawa
Japan	Tokai University Hospital_Cardiology	Kanagawa
Japan	Yokohama City University Hospital	Kanagawa
Japan	Yokohama City University Medical Center_Cardiovascular Center	Kanagawa
Japan	Yokohama Municipal Citizen's Hospital_Cardiology	Kanagawa
Japan	National Hospital Organization Kumamoto Medical Center_Cardiology	Kumamoto
Japan	NHO Kure Medical Center and Chugoku Cancer Center	Kure-shi, Hiroshima
Japan	Miyazaki Medical Association Hospital	Miyazaki-shi, Miyazaki
Japan	The Sakakibara Heart Institute of Okayama_Department of Cardiovascular Medicine	Okayama
Japan	Ishikiriseiki Hospital_Circulatory Medicine	Osaka
Japan	Osaka General Medical Center_Cardiology	Osaka
Japan	Tohoku University Hospital, Cardiovascular	Sendai-shi, Miyagi
Japan	Shiga University of Medical Science Hospital_Cardiology	Shiga
Japan	Juntendo University Shizuoka Hospital	Shizuoka
Japan	Kagawa Prefectural Central Hospital, Cardiovascular Medicine	Takamatsu-shi, Kagawa
Japan	Tokushima Prefectural Central Hospital_Cardiology	Tokushima
Japan	Teikyo University Hospital_Cardiology	Tokyo
Japan	Tsukuba Medical Center Hospital_Department of Cardiology	Tsukuba-shi, Ibaraki
Japan	Saiseikai Yokohamashi Nanbu Hospital_Cardiology	Yokohama-shi, Kanagawa
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Chungbuk National University Hospital	Cheongju
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Wonju Severance Christian Hospital	Gangwon-do
Korea, Republic of	MyongJi Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Ajou University Hospital	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul Saint Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan
Malaysia	Hospital Sultanah Bahiyah	Alor Setar	Kedah
Malaysia	Hospital Pulau Pinang	Georgetown
Malaysia	Hospital Raja Permaisuri Bainun Ipoh	Ipoh	Perak
Malaysia	Hospital Sultanah Aminah	Johor Bahru	Johor
Malaysia	Hospital Serdang	Kajang	Selangor
Malaysia	Hospital Raja Perempuan Zainab II	Kota Bharu
Malaysia	Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan	Kota Bharu, Kelantan
Malaysia	Sarawak Heart Centre	Kota Samarahan	Sarawak
Malaysia	Hospital Universiti Kebangsaan Malaysia	Kuala Lumpur
Malaysia	National Heart Institute	Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan	Pahang
Malaysia	Hospital Queen Elizabeth II	Sabah
Malaysia	Universiti Teknologi MARA, Sungai Buloh Campus	Sungai Buloh	Selangor
Mexico	Hospital Cardiológica Aguascalientes	Aguascalientes	Ags
Mexico	Centro Médico Nacional Siglo XXI	Cdmx
Mexico	Instituto Nacional de Cardiología Ignacio Chávez	Cdmx
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición	Cdmx
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara
Mexico	Nuevo Hospital Civil "Dr. Juan I. Menchaca"	Guadalajara	Jalisco
Mexico	Hospital Universitario Dr. José Eleuterio González	Monterrey
Mexico	Centro de Estudios Clinicos de Querétaro S.C.	Querétaro
Mexico	Centro de Atención e Investigación Cardiovascular del Potosi	San Luis Potosi
Mexico	Servicios Integrales Nova de Monterrey	San Nicolas de los Garza
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Jeroen Bosch Ziekenhuis	Den Bosch
Netherlands	Medisch Centrum Haaglanden Locatie Westeinde Ziekenhuis	Den Haag
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven
Netherlands	Groene Hart Ziekenhuis, locatie Bleuland	Gouda
Netherlands	UMC Groningen	Groningen
Netherlands	Tergooi, locatie Hilversum	Hilversum
Netherlands	Canisius-Wilhelmina Ziekenhuis	Nijmegen
Netherlands	Radboudumc	Nijmegen
Netherlands	Bravis Ziekenhuis	Roosendaal
Netherlands	Ikazia Ziekenhuis	Rotterdam
Netherlands	Maasstad Ziekenhuis	Rotterdam
Netherlands	Elisabeth-TweeSteden Ziekenhuis	Tilburg
Poland	Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok
Poland	American Heart of Poland S.A.	Bielsko-Biala
Poland	10 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bydgoszczy	Bydgoszcz
Poland	American Heart of Poland S.A.	Chrzanów	Malopolskie
Poland	SCANMED Spólka Akcyjna	Czestochowa
Poland	Wojewódzki Szpital Specjalistyczny im. NMP w Czestochowie	Czestochowa
Poland	American Heart of Poland S.A.	Dabrowa Górnicza	Slaskie
Poland	Wojewodzki Szpital Zespolony W Elblagu samodzielny publiczny zaklad opieki zdrowotnej	Elblag
Poland	Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk
Poland	Uniwersyteckie Centrum Kliniczne (UCK)	Gdansk
Poland	Szpitale Pomorskie Sp. z o.o.	Gdynia	Pomorskie
Poland	Szpital Miejski Nr 4 w Gliwicach Sp. z o.o., Oddzial Kardiologii	Gliwice
Poland	Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II	Grodzisk Mazowiecki
Poland	American Heart of Poland S.A.	Kedzierzyn-Kozle
Poland	SCANMED Spólka Akcyjna	Kluczbork
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital w Krakowie	Krakow
Poland	Intercard Spolka z ograniczona odpowiedzialnoscia	Krosno
Poland	SCANMED Spólka Akcyjna	Kutno
Poland	Uniwersytecki Szpital Kliniczny Im Wojskowej Akademii Medycznej Centralny Szpital Weteranow	Lodz
Poland	Wojewódzki Specjalistyczny Szpital im.Wl. Bieganskiego,	Lodz
Poland	Miedziowe Centrum Zdrowia s.a.	Lubin
Poland	1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ	Lublin
Poland	Podhalanski Szpital Specjalistyczny	Nowy Targ
Poland	Uniwersytecki Szpital Kliniczny w Opolu	Opole
Poland	Samodzielny Publiczny Zespól Zakladów Opieki Zdrowotnej w Ostrowi Mazowieckiej	Ostrów Mazowiecka
Poland	Zespól Zakladów Opieki Zdrowotnej w Ostrowie Wielkopolskim	Ostrow Wielkopolski	Wielkopolskie
Poland	Intercard Spolka z Ograniczona Odpowiedzialnoscia	Pinczow
Poland	Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan
Poland	Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan
Poland	Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu	Przemysl
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach	Pulawy	Lubelskie
Poland	Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie	Rzeszow	Podkarpackie Voivodeship
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych i Administracji w Rzeszowie	Rzeszow	Podkarpackie
Poland	Samodzielny Publiczny Zespol Opieki Zdrowotnej w Swidnicy	Swidnica
Poland	Uniwesytecki Szpital Kliniczny Nr 2 PUM W Szczecinie	Szczecin
Poland	Specjalistyczny Szpital Miejski im. M.Kopernika w Toruniu	Torun
Poland	American Heart of Poland S.A.	Tychy	Slaskie
Poland	Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw
Poland	Sródmiejskie Centrum Kliniczne,II Oddzial Kardiologii MSB, Klinika Chorób Serca CMKP	Warszawa
Poland	Szpital Grochowski im. dr med. Rafala Masztaka Sp. z o.o.	Warszawa
Poland	Szpital Wolski im. dr Anny Gostynskiej Sp. z o.o.	Warszawa
Poland	4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu	Wroclaw	Dolnoslaskie
Poland	Dolnoslaski Szpital Specjalistyczny Im. T.Marciniaka-Centrum Medycyny Ratunkowej	Wroclaw
Poland	Wojewodzki Szpital Specjalistyczny We Wroclawiu	Wroclaw
Poland	American Heart Of Poland S.A.	Zgierz
Spain	Hospital General Universitario Dr. Balmis	Alicante
Spain	Bellvitge Universitary Hospital	Badalona
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital de Lleida "Arnau de Vilanova"	Lleida
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Clinico de Santiago	Santiago de Compostela
Spain	Hospital Universitari Joan XXIII	Tarragona
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Alvaro Cunqueiro de Vigo	Vigo
Turkey	Afyonkarahisar Health Sciences University	Afyon
Turkey	Ankara Sehir Hastanesi Cardiology	Ankara
Turkey	Ankara University Medical Faculty	Ankara	Altindag
Turkey	Bursa Sehir Hastanesi Cardiology	Bursa
Turkey	Trakya University	Edirne
Turkey	Cerrahpasa Kardiyoloji Enstitüsü	Istanbul
Turkey	Dr. Siyami Ersek Gogus Kalp ve Damar Cerrahisi EAH	Istanbul
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul	Bakirkoy
Turkey	Kartal Kosuyolu Yuksek Ihtisas EAH	Istanbul
Turkey	Marmara University Medical Faculty	Istanbul
Turkey	T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastan	Istanbul
Turkey	Kocaeli University Medical Faculty	Izmit
Turkey	Erciyes University Cardiology	Kayseri
Turkey	Kayseri City Hospital	Kayseri
Turkey	Necmettin Erbakan University Hospital	Konya
Turkey	Kütahya Saglik Bilimleri Üniversitesi Evliya Çelebi Research and Training hospital	Kütahya
Turkey	Mersin City Hospital	Mersin
Turkey	Mersin University Cardiology	Mersin
Turkey	Antalya Egitim ve Arastirma Hastanesi	Muratpasa/ Antalya
Turkey	Ondokuz Mayis Universitesi Tip Fakültesi	Samsun
Turkey	Tokat Gaziosmanpasa Üniversitesi Tip Fakültesi Hastanesi	Tokat
United Kingdom	William Harvey Hospital	Ashford	Kent
United Kingdom	Blackpool Victoria Hospital	Blackpool	Lancashire
United Kingdom	Royal Bournemouth Hospital	Bournemouth	Dorset
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Golden Jubilee University National Hospital	Glasgow
United Kingdom	Royal Brompton and Harefield Hospitals	Harefield
United Kingdom	Kettering General Hospital	Kettering
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	Lincoln County Hospital	Lincoln
United Kingdom	Liverpool Heart & Chest Hospital	Liverpool
United Kingdom	Barts Heart Centre	London
United Kingdom	Kings College Hospital	London
United Kingdom	The James Cook University Hospital	Middlesbrough
United Kingdom	Freeman Hospital, Newcastle	Newcastle upon Tyne
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Queen Alexandra Hospital	Portsmouth
United Kingdom	Northern General Hospital	Sheffield
United Kingdom	Lister Hospital	Stevenage
United Kingdom	Morriston Hospital	Swansea
United Kingdom	Musgrove Park Hospital	Taunton
United Kingdom	Torbay Hospital	Torquay
United Kingdom	Royal Cornwall Hospital (Treliske)	Truro	Cornwall
United Kingdom	New Cross Hospital	Wolverhampton
United States	Advanced Cariodvascular LLC	Alexander City	Alabama
United States	PharmaTex Research, LLC	Amarillo	Texas
United States	Cardiology Associates_Asheville	Asheville	North Carolina
United States	Emory University Hospital - The Emory Clinic - Heart & Vascu	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	Austin Heart	Austin	Texas
United States	Northern Light Eastern Maine Medical Center	Bangor	Maine
United States	McLaren Bay Region	Bay City	Michigan
United States	MidMichigan Medical Center - Midland	Bay City	Michigan
United States	Grandview Medical Center	Birmingham	Alabama
United States	St. Luke's Idaho Cardiology Associates	Boise	Idaho
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Advanced Heart Care LLC	Bridgewater	New Jersey
United States	Jacobi Medical Center	Bronx	New York
United States	Trinity Medical WNY, PC	Buffalo	New York
United States	Penn State Hlth Holy Spirit Med Ctr	Camp Hill	Pennsylvania
United States	Aultman Hospital	Canton	Ohio
United States	Chambersburg Hospital	Chambersburg	Pennsylvania
United States	UNC Hospital HVC_Meadowmont	Chapel Hill	North Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Chattanooga Heart Institute	Chattanooga	Tennessee
United States	The Lindner Center for Research and Education at The Christ Hospital	Cincinnati	Ohio
United States	University of Cincinnati/UC Health	Cincinnati	Ohio
United States	Cleveland Clinic_Cleveland	Cleveland	Ohio
United States	Louis Stokes Clvlnd VA Med Ctr	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	University Hospitals Of Cleveland Medical Center	Cleveland	Ohio
United States	Valley Clinical Trials	Covina	California
United States	Dallas VA Medical Center	Dallas	Texas
United States	Liver Ins@ Mthdist DTX Med Cen	Dallas	Texas
United States	Danbury Hospital - Cardiology Department	Danbury	Connecticut
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Atlanta VAMC	Decatur	Georgia
United States	Essentia Health	Duluth	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	Saint Elizabeth Medical Center	Edgewood	Kentucky
United States	NorthShore University Health	Evanston	Illinois
United States	Wright State University and Premier Health Clinical Trials Research Alliance	Fairborn	Ohio
United States	Inova Heart and Vascular Institute	Fairfax	Virginia
United States	Eastern Shore Rsrch Inst, LLC	Fairhope	Alabama
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Northeast Georgia Medical Ctr	Gainesville	Georgia
United States	University of Florida	Gainesville	Florida
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	Moses H. Cone Mem Hosp	Greensboro	North Carolina
United States	Prisma Health Carolina Cardiology Consultants	Greenville	South Carolina
United States	The Heart House Haddon Heights	Haddon Heights	New Jersey
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Wake Forest University Health Sciences	High Point	North Carolina
United States	Memorial Healthcare	Hollywood	Florida
United States	Houston Methodist Hospital	Houston	Texas
United States	Prolato Clinical Research Center	Houston	Texas
United States	Texas Heart Inst Medical Ctr	Houston	Texas
United States	UT Health University of Texas	Houston	Texas
United States	Heart Center Rsrch_Hunstville	Huntsville	Alabama
United States	Indiana University Health Methodist Hosptial	Indianapolis	Indiana
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Baptist Heart Specialists	Jacksonville	Florida
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	UF Hepatology Jacksonville	Jacksonville	Florida
United States	University Of Kansas Hospital	Kansas City	Kansas
United States	Kettering Medical Center	Kettering	Ohio
United States	Knoxville Heart Group	Knoxville	Tennessee
United States	Tennova Healthcare-Turkey Creek Medical Center	Knoxville	Tennessee
United States	UMC of Southern Nevada	Las Vegas	Nevada
United States	Arkansas Cardiology Clinic	Little Rock	Arkansas
United States	S Denver Cardiology Associates	Littleton	Colorado
United States	Saint Joseph's Hospital Health Center	Liverpool	New York
United States	University of California, Los Angeles (UCLA)	Los Angeles	California
United States	VA Greater Los Angeles Hlthcare System	Los Angeles	California
United States	UofL Health Care Outpatient	Louisville	Kentucky
United States	Fairview Health Services	Maplewood	Minnesota
United States	Virtua Health	Marlton	New Jersey
United States	HCA Research Institute	McAllen	Texas
United States	Baptist Clin Res Institute	Memphis	Tennessee
United States	Aurora St. Luke's Medical Centr	Milwaukee	Wisconsin
United States	[Legal] Minneapolis Heart Institute Foundation & Allina Health System	Minneapolis	Minnesota
United States	Trinity Medical Group	Minot	North Dakota
United States	Mobile Heart USA Health Cardiology Clinic	Mobile	Alabama
United States	McLaren Macomb Health Care	Mount Clemens	Michigan
United States	Heart & Vascular Inst._Titus	Mount Pleasant	Texas
United States	Inspira Health	Mullica Hill	New Jersey
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale Ctr for Clin Invest	New Haven	Connecticut
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	Mount Sinai Morningside	New York	New York
United States	NYU Grossman School of Med	New York	New York
United States	Christiana Care Health Services, Inc.	Newark	Delaware
United States	Sentara Bayside Hospital	Norfolk	Virginia
United States	North Kansas City Hospital	North Kansas City	Missouri
United States	Parkway Cardiology Associates, PC	Oak Ridge	Tennessee
United States	South Oklahoma Heart Research, LLC	Oklahoma City	Oklahoma
United States	Methodist Physicians Clinic	Omaha	Nebraska
United States	University Of California Irvine	Orange	California
United States	Midwest Heart and Vascular Specialists	Overland Park	Kansas
United States	Ascension Sacred Heart	Pensacola	Florida
United States	Baptist Hospital Cardiology	Pensacola	Florida
United States	OSF HealthCare_Cardiovasc Inst	Peoria	Illinois
United States	McLaren Northern Michigan Hospital	Petoskey	Michigan
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	AtlantiCare Regional Medical Center	Pomona	New Jersey
United States	Maine Medical Center Bramhall	Portland	Maine
United States	Cardiovascular Research of Knoxville, LLC	Powell	Tennessee
United States	Rhode Island Hospital	Providence	Rhode Island
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	Monument Health Clinical Rsrch	Rapid City	South Dakota
United States	Bon Secours St. Mary's Hospital of Richmond, LLC	Richmond	Virginia
United States	Chippenham Medical Center	Richmond	Virginia
United States	McGuire VA Medical Center	Richmond	Virginia
United States	Reid Physician Associates	Richmond	Indiana
United States	University of Rochester	Rochester	New York
United States	Adventist HealthCare Shady Grove Medical Center	Rockville	Maryland
United States	Washington University School of Medicine_St. Louis	Saint Louis	Missouri
United States	Methodist Healthcare System of San Antonio	San Antonio	Texas
United States	Kaiser Permanente Viewridge Medical Offices	San Diego	California
United States	San Diego Cardiac Center	San Diego	California
United States	UCSD Medical Center	San Diego	California
United States	San Francisco V.A. Medical Center	San Francisco	California
United States	Intercoastal Medical Group	Sarasota	Florida
United States	Robert Packer Hospital	Sayre	Pennsylvania
United States	Swedish Medical Center_Seattle	Seattle	Washington
United States	University Of Washington_Seattle	Seattle	Washington
United States	Overton Brooks V.A. Medical Center	Shreveport	Louisiana
United States	Jadestone Clinical Research, LLC	Silver Spring	Maryland
United States	Sanford Research	Sioux Falls	South Dakota
United States	Ascension St. Mary's Research Institute - Michigan	Southfield	Michigan
United States	Mercy Research	Springfield	Missouri
United States	Prairie Cardiovascular Consultants, Ltd.	Springfield	Illinois
United States	Cardiology Associates of Fairfield County	Stamford	Connecticut
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	Cardiovascular Consultants of S. Georgia, LLC	Thomasville	Georgia
United States	Advanced Heart & Vein Center	Thornton	Colorado
United States	Mercy Health - St. Vincent Medical Center	Toledo	Ohio
United States	University of Toledo	Toledo	Ohio
United States	LA BioMed at Harbor UCLA Medical Center	Torrance	California
United States	Cardiolg Assoc Rsch LLC_Tupelo	Tupelo	Mississippi
United States	Westchester Medical Center	Valhalla	New York
United States	Cardiovascular Associates of the Delaware Valley	Vineland	New Jersey
United States	MedStar Hlth Res Institute	Washington	District of Columbia
United States	Interventional Cardiology Medical Group	West Hills	California
United States	Reading Hospital	West Reading	Pennsylvania
United States	Valley Health Link	Winchester	Virginia
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Winter Haven Hospital	Winter Haven	Florida
United States	Trinity Health Michigan Heart	Ypsilanti	Michigan
United States	Genesis Health Care System	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Novo Nordisk A/S	Duke Clinical Research Institute

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  China,  Czechia,  Denmark,  France,  Germany,  Greece,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Poland,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first occurrence of a 3-component major adverse cardiovascular event (MACE) endpoint comprising: Cardiovascular (CV) death, Non-fatal myocardial infarction (MI), Non-fatal stroke	Measured in months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Number of CV death, non-fatal MI, non-fatal stroke	Measured as count of events.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to first occurrence of a composite MACE endpoint consisting of: All-cause mortality, Non-fatal MI, Non-fatal stroke	Measured in months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Number of all-cause mortality, non-fatal MI, non-fatal stroke	Measured as count of events.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to first occurrence of non-fatal MI	Measured in months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to first occurrence of MI (fatal and non-fatal)	Measured in months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to first occurrence of non-fatal stroke	Measured in months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to first occurrence of stroke (fatal and non-fatal)	Measured in months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to first occurrence of a 3-component coronary MACE endpoint comprising:CV death, Non-fatal MI, Ischaemia-driven coronary revascularisation	Measured in months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to first occurrence of a 5-component expanded MACE endpoint comprising: CV death, Non-fatal MI, Non-fatal stroke, Ischaemia-driven coronary revascularisation, Heart failure (HF) hospitalisation or urgent HF visit	Measured in months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Number of CV death, non-fatal MI, non-fatal stroke, ischaemia-driven coronary revascularisation, or HF hospitalisation or urgent HF visit	Measired as count of events.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to first occurrence of a 3-component HF endpoint comprising: CV death, HF hospitalisation or urgent HF visit, Outpatient HF visit	Measured in months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Number of CV deaths, HF hospitalisation or urgent HF visits or outpatient HF visit	Measured in count of events.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to first occurrence of a 2-component HF endpoint comprising: CV death, HF hospitalisation or urgent HF visit	Measured as months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Number of CV deaths, HF hospitalisation or urgent HF visits	Measured in count of events.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to first occurrence of a 2-component expanded HF endpoint comprising: HF hospitalisation or urgent HF visit, Outpatient HF visit	Measured as months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Number of HF hospitalisation or urgent HF visit or outpatient HF visit	Measured as count of events.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Number of outpatient HF visit	Measured in count of events.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to occurrence of CV death	Measured as months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to occurrence of all-cause death	Measured as months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to first occurrence of 6-component vascular event endpoint: CV death, Non-fatal MI, Non-fatal stroke, Ischaemia-driven coronary revascularisation, Non-coronary revascularisation procedure, Any other non-coronary ischaemic event excluding stroke	Measured in months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Number of CV death, non-fatal MI and non-fatal stroke, ischaemia-driven coronary revascularisation, non-coronary revascularisation procedure, or any other non-coronary ischaemic event excluding stroke	Measured as count of events.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Number of ischaemia-driven coronary revascularisation	Measured as count of events.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Time to first occurrence of ischaemia-driven coronary revascularisation or any non-coronary revascularisation	Measured in months.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Number of ischaemia-driven coronary revascularisation or any non-coronary revascularisation	Measured as count of events.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Number of cardiovascular hospitalisations	Measured as count of events.	From randomisation (month 0) to 1 month/ 30 days
Secondary	Number of cardiovascular hospitalisations	Measured as count of events.	From randomisation (month 0) to 12 months
Secondary	Number of hospitalisations with infection as primary cause or death due to infection	Measured as count of events.	From randomisation (month 0) to end-of-study (up to 25 months)
Secondary	Change in high-sensitivity C-reactive protein (hs-CRP)	Measured as ratio to baseline.	From randomisation (month 0) to 6 months