Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial (NCT05581303) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
United States7,297 participantsStarted 2022-12-14
Plain-language summary
The primary objective of this trial 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).
Who can participate
Age range18 Years – 85 Years
SexALL
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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)
What they're measuring
1
Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first