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

ID#: NCT05581303

Age: 18 - 85 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: December 14, 2022

End Date: December 16, 2026

Contact Information:
Amgen Call Center
866-572-6436
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).
Eligibility:

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 (presumed type 1 event due to plaque rupture/erosion) and/or

- Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor.

Exclusion Criteria:

- 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)
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