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Recruiting Phase 3 NCT07293260

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

Phase 3 – large-scale trial before approval
Conditions: Cardiovascular Disease

Sponsor: Amgen

trial.available_in: БГ
Overview
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).
Who can participate
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).
Locations 10
Australia (1)
Advara HeartCare Wesley
Auchenflower , Queensland
Canada (1)
North York Diagnostic and Cardiac Centre
Vaughan , Ontario
China (1)
Peking University First Hospital
Beijing , Beijing Municipality
Denmark (1)
Regionshospitalet Gødstrup
Herning
France (1)
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
Nice
Italy (1)
Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna
Ferrara
Japan (1)
Tomakomai City Hospital
Tomakomai-shi , Hokkaido
Netherlands (1)
Tergooiziekenhuizen, locatie Hilversum
Hilversum
Spain (1)
Hospital Universitario Virgen Macarena
Seville , Andalusia
United States (1)
Bridgeport Hospital
Bridgeport , Connecticut
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
35 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
23.03.2026
Completion date
15.06.2028
Registry ID
NCT07293260
Source
anzctr
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