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NCT07293260PHASE3Recruiting

Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial

Amgen

Start Date

3/23/2026

Completion Date

6/15/2028

Summary

The primary objective of this trial is to evaluate the effect of olpasiran, compared to placebo, on non-calcified plaque (NCP) volume as measured by Coronary Computed Tomography Angiography (CCTA).

Eligibility Criteria

Age Range: 35 years to 80 years

Inclusion Criteria: * Age 35 to ≤ 80 years. * Lp(a) ≥ 200 nmol/L during screening. * Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA. * History of myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or coronary revascularization by percutaneous coronary intervention. Exclusion Criteria: * History of coronary artery bypass graft (CABG). * Moderate to severe renal dysfunction. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN), or total bilirubin (TBL) \> 2 x ULN during screening. * History of hemorrhagic stroke. * History of major bleeding disorder. * Planned cardiac surgery or arterial revascularization. * Severe heart failure. * Current, recent, or planned lipoprotein apheresis. * Previously received ribonucleic acid therapy specifically targeting Lp(a).

Interventions

DRUG

Olpasiran

DRUG

Placebo

Interested in This Trial?

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Conditions

Cardiovascular Disease

Locations

Bridgeport Hospital

Bridgeport, Connecticut 06610

United States

Jacksonville Center for Clinical Research

Jacksonville, Florida 32216

United States

Midwest Heart and Vascular Specialists

Overland Park, Kansas 66211

United States

Flourish Bowie

Bowie, Maryland 20715

United States

Montefiore Medical Center - Bronx

Philadelphia, Pennsylvania 19141

United States

Vital Heart and Vein

Humble, Texas 77338

United States

Advara HeartCare Wesley

Auchenflower, Queensland 4066

Australia

University of The Sunshine Coast Clinical Trials, Sippy Downs

Sippy Downs, Queensland 4556

Australia

Advara HeartCare Leabrook

Leabrook, South Australia 5068

Australia

North York Diagnostic and Cardiac Centre

Vaughan, Ontario L6A 4N9

Canada

Peking University First Hospital

Beijing, Beijing Municipality 100034

China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan 450052

China

The Second Xiangya Hospital of Central South University

Changsha, Hunan 410011

China

The Third Xiangya Hospital of Central South University

Changsha, Hunan 410013

China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu 210011

China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia 750004

China

Shaanxi Provincial Peoples Hospital

Xi'an, Shaanxi 710068

China

Jinan Central Hospital

Jinan, Shandong 250013

China

Regionshospitalet Gødstrup

Herning, 7400

Denmark

Regionshospitalet Viborg

Viborg, 8800

Denmark

Centre Hospitalier Universitaire de Nice - Hopital Pasteur

Nice, 06000

France

Centre Hospitalier Universitaire de Bordeaux Hopital Haut-Leveque

Pessac, 33604

France

Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

Toulouse, 31059

France

Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau

Tours, 37044

France

Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

Berlin, 12203

Germany

Universitaetsklinikum Essen

Essen, 45147

Germany

Universitaetsklinikum Frankfurt

Frankfurt am Main, 60590

Germany

Klinikum rechts der Isar der TUM

München, 80636

Germany

Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna

Ferrara, 44124

Italy

IRCCS Centro Cardiologico Monzino

Milan, 20138

Italy

IRCCS Policlinico San Donato

San Donato Milanese, 20097

Italy

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, 10128

Italy

Tomakomai City Hospital

Tomakomai-shi, Hokkaido 053-8567

Japan

Osaka Keisatsu Hospital

Osaka, Osaka 543-0042

Japan

University of Yamanashi Hospital

Chuo-shi, Yamanashi 409-3898

Japan

Tergooiziekenhuizen, locatie Hilversum

Hilversum, 1201 DA

Netherlands

Hospital Universitario Virgen Macarena

Seville, Andalusia 41009

Spain

Hospital Alvaro Cunqueiro

Vigo, Galicia 36312

Spain

Hospital Universitari i Politecnic La Fe

Valencia, Valencia 46026

Spain

Hospital Universitario Ramon y Cajal

Madrid, 28023

Spain