OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
Purpose
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]).
Condition
- Cardiovascular Disease
Eligibility
- Eligible Ages
- Between 50 Years and 105 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Olpasiran |
Participants will receive subcutaneous (SC) olpasiran. |
|
|
Placebo Comparator Placebo |
Participants will receive SC placebo. |
|
Recruiting Locations
Medstar Franklin Square Medical Center
Hyattsville 4358821, Maryland 4361885 20782
Hyattsville 4358821, Maryland 4361885 20782
More Details
- Status
- Recruiting
- Sponsor
- Amgen