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Recruiting Phase 3 NCT07136012

OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events

Trial Parameters

Condition Cardiovascular Disease
Sponsor Amgen
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 11,000
Sex ALL
Min Age 50 Years
Max Age 105 Years
Start Date 2025-08-22
Completion 2031-10-20
Interventions
OlpasiranPlacebo

Brief Summary

The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\[a\]).

Eligibility Criteria

Inclusion Criteria: * Age ≥50 years * Lp(a)≥ 200 nmol/L during screening * Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis Exclusion Criteria: * Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia) * Prior or planned arterial revascularization * History of major bleeding disorder

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