Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD

Cardiovascular Disease and Lipoprotein(a) Clinical Trial

— Lp(a)HORIZON  

Official title:

A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With Established Cardiovascular Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04023552
• Other study ID #: CTQJ230A12301
• Secondary ID: CTQJ230A12301201
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 12, 2019
• Est. completion date: May 30, 2025

Study information

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

Clinical Trial Summary

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8323
• Est. completion date: May 30, 2025
• Est. primary completion date: May 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Key Inclusion Criteria

• Lp(a) = 70 mg/dL at the screening visit, measured at the Central laboratory

• Myocardial infarction: = 3 months from screening and randomization to = 10 years prior to the screening visit

• Ischemic stroke: = 3 months from screening and randomization to = 10 years prior to the screening visit

• Clinically significant symptomatic peripheral artery disease

Key Exclusion Criteria

• Uncontrolled hypertension

• Heart failure New York Heart Association (NYHA) class IV

• History of malignancy of any organ system

• History of hemorrhagic stroke or other major bleeding

• Platelet count =LLN

• Active liver disease or hepatic dysfunction

• Significant kidney disease

• Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply at the end.

Related Conditions & MeSH terms

• Cardiovascular Disease and Lipoprotein(a)
• Cardiovascular Diseases

Intervention

Drug:
• TQJ230
TQJ230 80 mg injected monthly administered subcutaneously
• Placebo
Placebo to match TQJ230 prefilled syringe to be injected subcutaneously

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba
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	Capital Federal
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Corrientes
Argentina	Novartis Investigative Site	Mar del Plata	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	San Luis
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Tucuman	San Miguel De Tucuman
Australia	Novartis Investigative Site	Camperdown	New South Wales
Australia	Novartis Investigative Site	Chemside	Queensland
Australia	Novartis Investigative Site	Clayton	Victoria
Australia	Novartis Investigative Site	Liverpool	New South Wales
Australia	Novartis Investigative Site	Perth	Western Australia
Australia	Novartis Investigative Site	Southport	Queensland
Australia	Novartis Investigative Site	Woolloongabba	Queensland
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Innsbruck
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Austria	Novartis Investigative Site	Salzburg
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Austria	Novartis Investigative Site	Wien
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Belgium	Novartis Investigative Site	Brugge
Belgium	Novartis Investigative Site	Bruxelles
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Belgium	Novartis Investigative Site	Huy
Belgium	Novartis Investigative Site	Kortrijk
Belgium	Novartis Investigative Site	Mechelen
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Greece	Novartis Investigative Site	Athens	GR
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Hungary	Novartis Investigative Site	Baja
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Iceland	Novartis Investigative Site	Kopavogur
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Portugal	Novartis Investigative Site	Setubal
Puerto Rico	Novartis Investigative Site	Ponce
Romania	Novartis Investigative Site	Baia Mare
Romania	Novartis Investigative Site	Baia Mare
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Buzau
Romania	Novartis Investigative Site	Craiova	Jud Dolj
Romania	Novartis Investigative Site	Iasi	Jud Iasi
Romania	Novartis Investigative Site	Iasi
Romania	Novartis Investigative Site	Timisoara	Timis
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Ivanovo
Russian Federation	Novartis Investigative Site	Izhevsk
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Kirov
Russian Federation	Novartis Investigative Site	Korolev Moscow Region
Russian Federation	Novartis Investigative Site	Krasnodar
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Perm
Russian Federation	Novartis Investigative Site	Petrozavodsk
Russian Federation	Novartis Investigative Site	Rostov On Don
Russian Federation	Novartis Investigative Site	Ryazan
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Russian Federation	Novartis Investigative Site	Samara
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Sochy
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St.- Petersburg
Russian Federation	Novartis Investigative Site	Tomsk
Russian Federation	Novartis Investigative Site	Ulyanovsk
Russian Federation	Novartis Investigative Site	Vsevolozhsk
Russian Federation	Novartis Investigative Site	Yaroslavl
Russian Federation	Novartis Investigative Site	Yekaterinburg
Slovakia	Novartis Investigative Site	Banska Bystrica	Slovak Republic
Slovakia	Novartis Investigative Site	Bardejov
Slovakia	Novartis Investigative Site	Bardejov
Slovakia	Novartis Investigative Site	Bardejovske Kupele	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
Slovakia	Novartis Investigative Site	Brezno
Slovakia	Novartis Investigative Site	Dolny Kubin
Slovakia	Novartis Investigative Site	Handlova	SVK
Slovakia	Novartis Investigative Site	Komarno
Slovakia	Novartis Investigative Site	Komarno	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Lucenec
Slovakia	Novartis Investigative Site	Nitra
Slovakia	Novartis Investigative Site	Nitra
Slovakia	Novartis Investigative Site	Nitra
Slovakia	Novartis Investigative Site	Nitra	Slovak Republic
Slovakia	Novartis Investigative Site	Nove Zamky
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	Presov
Slovakia	Novartis Investigative Site	Rimavska Sobota
Slovakia	Novartis Investigative Site	Rimavska Sobota	Slovak Republic
Slovakia	Novartis Investigative Site	Roznava	Slovak Republic
Slovakia	Novartis Investigative Site	Svidnik
Slovakia	Novartis Investigative Site	Trnava
Slovakia	Novartis Investigative Site	Turcianske Teplice	Okr Turcianske Teplice
Slovakia	Novartis Investigative Site	Zilina	Zilinsky Kraj
Slovenia	Novartis Investigative Site	Ljubljana
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town	Western Cape
South Africa	Novartis Investigative Site	George	Western Cape
South Africa	Novartis Investigative Site	Soweto	Gauteng
Spain	Novartis Investigative Site	A Coruna
Spain	Novartis Investigative Site	Badalona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Caceres	Extremadura
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	Hospitalet de Llobregat	Barcelona
Spain	Novartis Investigative Site	Huelva
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Reus	Cataluna
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	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Zaragoza
Sweden	Novartis Investigative Site	Goethenburg
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Stockholm
Switzerland	Novartis Investigative Site	Basel
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Geneve 14
Switzerland	Novartis Investigative Site	Lausanne
Switzerland	Novartis Investigative Site	Liestal
Switzerland	Novartis Investigative Site	Zuerich
Taiwan	Novartis Investigative Site	Hsinchu
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Keelung City
Taiwan	Novartis Investigative Site	Taichung	Taiwan ROC
Taiwan	Novartis Investigative Site	Tainan
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taoyuan
Taiwan	Novartis Investigative Site	Yilan
Turkey	Novartis Investigative Site	Ankara	Cankaya
Turkey	Novartis Investigative Site	Haydarpasa Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Mersin
Turkey	Novartis Investigative Site	Meselik	Eskisehir
Turkey	Novartis Investigative Site	Samsun
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Bournemouth
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Cardiff
United Kingdom	Novartis Investigative Site	Cardiff	Wales
United Kingdom	Novartis Investigative Site	Chertsey	Surrey
United Kingdom	Novartis Investigative Site	Chesterfield
United Kingdom	Novartis Investigative Site	Chichester	West Sussex
United Kingdom	Novartis Investigative Site	Dorchester	Dorset
United Kingdom	Novartis Investigative Site	Dundee	Perthshire
United Kingdom	Novartis Investigative Site	Edinburgh
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Harrow
United Kingdom	Novartis Investigative Site	Leicester
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London	GBR
United Kingdom	Novartis Investigative Site	London	Greater London
United Kingdom	Novartis Investigative Site	Londonderry
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Middlesbrough
United Kingdom	Novartis Investigative Site	Middlesex
United Kingdom	Novartis Investigative Site	Newcastle upon Tyne
United Kingdom	Novartis Investigative Site	Newport
United Kingdom	Novartis Investigative Site	Norwich
United Kingdom	Novartis Investigative Site	Plymouth
United Kingdom	Novartis Investigative Site	Portadown	Nothern Ireland
United Kingdom	Novartis Investigative Site	Preston	Lancashire
United Kingdom	Novartis Investigative Site	Rhyl	Wales
United Kingdom	Novartis Investigative Site	Rochdale	North Manchester
United Kingdom	Novartis Investigative Site	Sheffield
United Kingdom	Novartis Investigative Site	Sketty	Swansea
United Kingdom	Novartis Investigative Site	Stockton On Tees	Cleveland
United Kingdom	Novartis Investigative Site	Sunderland	Tyne And Wear
United Kingdom	Novartis Investigative Site	Taunton	Somerset
United Kingdom	Novartis Investigative Site	Tyne And Wear
United Kingdom	Novartis Investigative Site	West Midlands
United Kingdom	Novartis Investigative Site	Wiltshire
United Kingdom	Novartis Investigative Site	Wrexham
United States	Akron Hospital Summa Health System Akron Hospital	Akron	Ohio
United States	Novartis Investigative Site	Akron	Ohio
United States	Albany Medical College	Albany	New York
United States	Novartis Investigative Site	Alexandria	Louisiana
United States	SEC Clinical Research LLC .	Andalusia	Alabama
United States	Emory University Heart Disease Prevention Cent	Atlanta	Georgia
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Aurora	Colorado
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Baton Rouge	Louisiana
United States	Novartis Investigative Site	Belzoni	Mississippi
United States	Cardiovascular Res Found	Beverly Hills	California
United States	Novartis Investigative Site	Beverly Hills	California
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Boca Raton	Florida
United States	Novartis Investigative Site	Bogalusa	Louisiana
United States	Novartis Investigative Site	Bossier City	Louisiana
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Bountiful	Utah
United States	Novartis Investigative Site	Bradenton	Florida
United States	Novartis Investigative Site	Brandon	Florida
United States	Novartis Investigative Site	Bridgeport	Connecticut
United States	Novartis Investigative Site	Canton	Ohio
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Rush University Medical Center .	Chicago	Illinois
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Columbia	Maryland
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Cottonwood	Arizona
United States	Novartis Investigative Site	Covina	California
United States	Novartis Investigative Site	Covington	Louisiana
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Dallas	Texas
United States	UT Southwestern Medical Center .	Dallas	Texas
United States	Novartis Investigative Site	Danville	Virginia
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Dunwoody	Georgia
United States	Novartis Investigative Site	Eunice	Louisiana
United States	Inova Fairfax Hospital .	Falls Church	Virginia
United States	Novartis Investigative Site	Falls Church	Virginia
United States	Novartis Investigative Site	Flint	Michigan
United States	Novartis Investigative Site	Fort Lauderdale	Florida
United States	Novartis Investigative Site	Fort Mill	South Carolina
United States	Novartis Investigative Site	Fort Washington	Maryland
United States	Novartis Investigative Site	Germantown	Tennessee
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	Genesys Regional Medical Center Ascension Genesys Hosp	Grand Blanc	Michigan
United States	Novartis Investigative Site	Grand Blanc	Michigan
United States	Medication Management LLC .	Greensboro	North Carolina
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Hammond	Louisiana
United States	Novartis Investigative Site	Hartford	Connecticut
United States	Novartis Investigative Site	High Point	North Carolina
United States	Novartis Investigative Site	Houma	Louisiana
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Huntington Beach	California
United States	Novartis Investigative Site	Huntsville	Alabama
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Iowa City	Iowa
United States	Novartis Investigative Site	Jackson	Tennessee
United States	East Coast Institute for Research .	Jacksonville	Florida
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Kalamazoo	Michigan
United States	Novartis Investigative Site	Kansas City	Kansas
United States	Novartis Investigative Site	La Jolla	California
United States	Horizon Research Grp CLCZ696B2314	Lafayette	Louisiana
United States	Novartis Investigative Site	Lancaster	Pennsylvania
United States	Alpine Research Association .	Layton	Utah
United States	Novartis Investigative Site	Lebanon	New Hampshire
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Livingston	Texas
United States	Novartis Investigative Site	Long Beach	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Manassas	Virginia
United States	Novartis Investigative Site	Manhasset	New York
United States	Saint Johns Hospital	Maplewood	Minnesota
United States	Novartis Investigative Site	Marion	Ohio
United States	Grace Research .	Marshall	Texas
United States	Novartis Investigative Site	Metairie	Louisiana
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Milwaukee	Wisconsin
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Mobile	Alabama
United States	West Virginia University Hospital WVU Ruby Memorial Hospital	Morgantown	West Virginia
United States	Novartis Investigative Site	Murray	Utah
United States	Novartis Investigative Site	Naples	Florida
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	New Orleans	Louisiana
United States	Tulane Uni Health Sciences Center .	New Orleans	Louisiana
United States	Lenox Hill Hospital Northwell Health Systems	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Norfolk	Virginia
United States	Novartis Investigative Site	Northridge	California
United States	Heartland Clinical Research Inc Dept of Heartland ClinRes 5	Omaha	Nebraska
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Opelousas	Louisiana
United States	Novartis Investigative Site	Orange	California
United States	Novartis Investigative Site	Park Ridge	Illinois
United States	Novartis Investigative Site	Petoskey	Michigan
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Port Charlotte	Florida
United States	Novartis Investigative Site	Port Orange	Florida
United States	Novartis Investigative Site	Portland	Oregon
United States	Cardiovascular Res of Knoxville LLC .	Powell	Tennessee
United States	Novartis Investigative Site	Powell	Tennessee
United States	Novartis Investigative Site	Providence	Rhode Island
United States	Accellacare US Inc	Raleigh	North Carolina
United States	Novartis Investigative Site	Rapid City	South Dakota
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Ridgewood	New Jersey
United States	Rochester Regional Health Main Center	Rochester	New York
United States	Strong Memorial Hospital	Rochester	New York
United States	Novartis Investigative Site	Rockville	Maryland
United States	Novartis Investigative Site	Saginaw	Michigan
United States	Novartis Investigative Site	Saint Augustine	Florida
United States	Mercy Hospital St Louis .	Saint Louis	Missouri
United States	Mercy South	Saint Louis	Missouri
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Saint Peters	Missouri
United States	The University of Utah .	Salt Lake City	Utah
United States	University of California San Diego .	San Diego	California
United States	Novartis Investigative Site	San Francisco	California
United States	UCSF .	San Francisco	California
United States	Novartis Investigative Site	Sanford	North Carolina
United States	Novartis Investigative Site	Santa Ana	California
United States	Novartis Investigative Site	Scarborough	Maine
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Seattle	Washington
United States	Univ of Washington Medical Center .	Seattle	Washington
United States	Novartis Investigative Site	Shelby	North Carolina
United States	Grace Research Llc .	Shreveport	Louisiana
United States	Novartis Investigative Site	Shreveport	Louisiana
United States	Novartis Investigative Site	Slidell	Louisiana
United States	Novartis Investigative Site	Southampton	New York
United States	Novartis Investigative Site	Southaven	Mississippi
United States	Novartis Investigative Site	Stanford	California
United States	Novartis Investigative Site	Stockton	California
United States	Novartis Investigative Site	Summerville	South Carolina
United States	Novartis Investigative Site	Summit	New Jersey
United States	Novartis Investigative Site	Sun City West	Arizona
United States	Novartis Investigative Site	Temple	Texas
United States	Novartis Investigative Site	Thomasville	Georgia
United States	Novartis Investigative Site	Tomball	Texas
United States	Novartis Investigative Site	Topeka	Kansas
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Waterbury	Connecticut
United States	Novartis Investigative Site	Wellington	Florida
United States	Novartis Investigative Site	West Hills	California
United States	Novartis Investigative Site	Winston-Salem	North Carolina
United States	Wake Forest Uni Baptist MC .	Winston-Salem	North Carolina
United States	Novartis Investigative Site	Wyoming	Michigan
United States	Novartis Investigative Site	Yardley	Pennsylvania
United States	Novartis Investigative Site	Yazoo City	Mississippi
United States	Novartis Investigative Site	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,  Czechia,  Denmark,  France,  Germany,  Greece,  Guatemala,  Hong Kong,  Hungary,  Iceland,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Peru,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) = 70 mg/dL	Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and (Lp(a) = 70 mg/dL)	approximately 4 years
Primary	Time to the first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in a population of patients with elevated Lp(a) = 90 mg/dL.	Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and (Lp(a) = 90 mg/dL)	approximately 4 years
Secondary	Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of major adverse cardiovascular events (CV death, non-fatal MI, and non-fatal stroke)	Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of the MACE composite of CV death, nonfatal MI and non-fatal stroke.	approximately 4 years
Secondary	Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of coronary heart disease: coronary heart disease death, non-fatal MI, urgent coronary re-vascularization requiring hospitalization	Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of the composite of coronary heart disease (CHD) outcomes: death due to CHD, nonfatal MI and urgent coronary revascularization requiring hospitalization.	approximately 4 years
Secondary	Time to Clinical endpoint Committee confirmed all-cause death	Evaluation by clinical endpoint committee the rate of all-cause death	approximately 4 years
Secondary	Change in Lp(a) in the log scale from baseline	Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in lowering the Lp(a) level at 1 year	Baseline, year 1