Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial

• Status: Not yet recruiting
• Trial end date: 2026-12-23
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• Age 18 to ≤ 85 years

• Lp(a) ≥ 200 nmol/L during screening

• History of ASCVD as evidenced by history of either:

• Myocardial infarction and/or

• Coronary revascularization with percutaneous coronary intervention with stenting AND at least 1 additional risk factor

Exclusion Criteria:

• Severe renal dysfunction

• Active liver disease, known hepatitis, or hepatic dysfunction

• 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)