A Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Safety, Tolerability, and Effect of Olpasiran on Coronary Artery Plaque Burden Assessed by Coronary Computed Tomography Angiography in Participants With Stable Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)
Amgen
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
- Age range
- 35–80 years
- Sex
- All
- 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) \>…
Interventions
- DrugOlpasiran
Olpasiran will be administered SC.
- DrugPlacebo
Placebo will be administered SC.
Locations (40)
- Bridgeport HospitalBridgeport, Connecticut
- Jacksonville Center for Clinical ResearchJacksonville, Florida
- Midwest Heart and Vascular SpecialistsOverland Park, Kansas
- Flourish BowieBowie, Maryland
- Montefiore Medical Center - BronxPhiladelphia, Pennsylvania
- Vital Heart and VeinHumble, Texas