OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
Recruiting
Phase 3Interventional Study
Cardiovascular Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 105
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
11,000 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for
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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\[a\]).
Trial Locations
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Status
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 lim…
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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