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Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
About
Brief 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).
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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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Study Stats
Protocol No.
23-000778
Category
Heart/Cardiovascular Diseases
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood