NCT07136012 OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
| NCT ID | NCT07136012 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Amgen |
| Condition | Cardiovascular Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 11,000 participants |
| Start Date | 2025-08-22 |
| Primary Completion | 2031-10-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 11,000 participants in total. It began in 2025-08-22 with a primary completion date of 2031-10-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
MD
STUDY DIRECTOR
Amgen
Frequently Asked Questions
Who can join the NCT07136012 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 105 Years, studying Cardiovascular Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07136012 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 11,000 participants.
Is NCT07136012 currently recruiting?
Yes, NCT07136012 is actively recruiting participants. Contact the research team at medinfo@amgen.com for enrollment information.
Where is the NCT07136012 trial being conducted?
This trial is being conducted at Alexander City, United States, Birmingham, United States, Birmingham, United States, Daphne, United States and 11 additional locations.
Who is sponsoring the NCT07136012 clinical trial?
NCT07136012 is sponsored by Amgen. The principal investigator is MD at Amgen. The trial plans to enroll 11,000 participants.