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Clinical Trials in Spain / NCT07293260
Recruiting Phase 3

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

NCT07293260 · tracked via the Priya Life Science Spain tracker
Sponsor
Amgen
Phase
Phase 3
Started
2026-03-23
Last updated
2026-04-16

Condition(s) studied

Cardiovascular Disease

Investigational drug(s) / intervention(s)

Olpasiran →Placebo

Olpasiran: Olpasiran will be administered SC.

Placebo: Placebo will be administered SC.

Study 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

Sex
ALL
Min age
35 Years
Max age
80 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Change in NCP Volume from Baseline to Week 72 — Baseline to Week 72

Trial sites (40)

FacilityCityRegionStatus
Bridgeport Hospital Bridgeport Connecticut Recruiting
Jacksonville Center for Clinical Research Jacksonville Florida Recruiting
Midwest Heart and Vascular Specialists Overland Park Kansas Recruiting
Flourish Bowie Bowie Maryland Recruiting
Montefiore Medical Center - Bronx Philadelphia Pennsylvania Recruiting
Vital Heart and Vein Humble Texas Recruiting
Advara HeartCare Wesley Auchenflower Queensland Recruiting
University of The Sunshine Coast Clinical Trials, Sippy Downs Sippy Downs Queensland Recruiting
Advara HeartCare Leabrook Leabrook South Australia Recruiting
North York Diagnostic and Cardiac Centre Vaughan Ontario Recruiting
Peking University First Hospital Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
The Second Xiangya Hospital of Central South University Changsha Hunan Recruiting
The Third Xiangya Hospital of Central South University Changsha Hunan Recruiting
The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu Recruiting
General Hospital of Ningxia Medical University Yinchuan Ningxia Recruiting
Shaanxi Provincial Peoples Hospital Xi'an Shaanxi Recruiting
Jinan Central Hospital Jinan Shandong Recruiting
Regionshospitalet Gødstrup Herning Denmark Recruiting
Regionshospitalet Viborg Viborg Denmark Recruiting
Centre Hospitalier Universitaire de Nice - Hopital Pasteur Nice France Recruiting
Centre Hospitalier Universitaire de Bordeaux Hopital Haut-Leveque Pessac France Recruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil Toulouse France Recruiting
Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau Tours France Recruiting
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin Berlin Germany Recruiting
Universitaetsklinikum Essen Essen Germany Recruiting
Universitaetsklinikum Frankfurt Frankfurt am Main Germany Recruiting
Klinikum rechts der Isar der TUM München Germany Recruiting
Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna Ferrara Italy Recruiting
IRCCS Centro Cardiologico Monzino Milan Italy Recruiting
IRCCS Policlinico San Donato San Donato Milanese Italy Recruiting
Azienda Ospedaliera Ordine Mauriziano di Torino Torino Italy Recruiting
Tomakomai City Hospital Tomakomai-shi Hokkaido Recruiting
Osaka Keisatsu Hospital Osaka Osaka Recruiting
University of Yamanashi Hospital Chuo-shi Yamanashi Recruiting
Tergooiziekenhuizen, locatie Hilversum Hilversum Netherlands Recruiting
Hospital Universitario Virgen Macarena Seville Andalusia Recruiting
Hospital Alvaro Cunqueiro Vigo Galicia Recruiting
Hospital Universitari i Politecnic La Fe Valencia Valencia Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07293260 on ClinicalTrials.gov ↗ ← All trials in Spain