OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
- Registration Number
- NCT07136012
- Lead Sponsor
- Amgen
- 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\[a\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 11000
- Age ≥50 years
- Lp(a)≥ 200 nmol/L during screening
- Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olpasiran Olpasiran Participants will receive subcutaneous (SC) olpasiran. Placebo Placebo Participants will receive SC placebo.
- Primary Outcome Measures
Name Time Method Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First Up to approximately 6.2 years
- Secondary Outcome Measures
Name Time Method Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First Up to approximately 6.2 years Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First Up to approximately 6.2 years Percent Change From Baseline to Week 48 Lp(a) Levels Baseline and Week 48 Time to Myocardial Infarction Up to approximately 6.2 years Time to CHD Death or Myocardial Infarction, Whichever Occurs First Up to approximately 6.2 years Time to Urgent Coronary Revascularization Up to approximately 6.2 years Time to Coronary Revascularization Up to approximately 6.2 years Time to CHD Death Up to approximately 6.2 years Time to Cardiovascular Death Up to approximately 6.2 years Time to Death by any Cause Up to approximately 6.2 years Time to Ischemic Stroke Up to approximately 6.2 years Serum Concentration of Olpasiran Up to Week 48 Number of Participants with Treatment Emergent Adverse Events (TEAEs) Up to approximately 6.2 years Including serious adverse events and adverse events leading to discontinuation of investigational product.
Trial Locations
- Locations (137)
Alliance Clinical Research
🇺🇸San Diego, California, United States
Manshadi Heart Institute
🇺🇸Stockton, California, United States
Clearwater Cardiovascular Consultants
🇺🇸Clearwater, Florida, United States
Franciscan Health Indianapolis
🇺🇸Indianapolis, Indiana, United States
Cardiovascular Research of Northwest Indiana LLC
🇺🇸Munster, Indiana, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Capitol Cardiology Associates
🇺🇸Lanham, Maryland, United States
New Jersey Medcare / New Jersey Heart
🇺🇸Linden, New Jersey, United States
Ima Clinical Research - Warren
🇺🇸Warren Township, New Jersey, United States
Niagara Falls Memorial Medical Center
🇺🇸Niagara Falls, New York, United States
Scroll for more (127 remaining)Alliance Clinical Research🇺🇸San Diego, California, United States