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).
Eligibility
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).
