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

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)

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).

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).