Olpasiran to prevent a first major coronary event in people with high Lp(a)
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants With Elevated Lipoprotein(a)
This trial tests whether olpasiran can lower the chance of a first heart attack, death from coronary heart disease, or urgent coronary revascularization in people age 50 and older with very high lipoprotein(a).
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 11000 (estimated) |
| Ages | 50 Years to 105 Years |
| Sex | All |
| Sponsor | Amgen Industry-sponsored |
| Locations | 244 sites (Alexander City, Alabama and 243 other locations) |
| Trial ID | NCT07136012 on ClinicalTrials.gov |
What this trial studies
This Phase 3 interventional trial randomizes people with elevated Lp(a) and multiple cardiovascular risk factors or evidence of atherosclerosis to receive olpasiran or placebo and follows them for a first major coronary event (CHD death, myocardial infarction, or urgent coronary revascularization). Eligible participants are age 50 or older with Lp(a) ≥200 nmol/L and no prior acute atherothrombotic events or planned arterial revascularization. The study compares event rates between the olpasiran and placebo groups to determine whether lowering Lp(a) translates into fewer first major coronary events. The trial is conducted at U.S. clinical sites including centers in Alabama.
Who should consider this trial
Good fit: Ideal candidates are adults age 50 or older with Lp(a) ≥200 nmol/L who have multiple atherosclerotic cardiovascular risk factors or evidence of atherosclerosis but no prior heart attack, stroke, or revascularization and no major bleeding disorder.
Not a fit: People with prior atherothrombotic events, prior or planned arterial revascularization, major bleeding disorders, or normal/low Lp(a) are unlikely to benefit from this trial's intervention or are excluded.
Why it matters
Potential benefit: If successful, olpasiran could reduce the risk of a first major coronary event in people with markedly elevated Lp(a).
How similar studies have performed: Earlier olpasiran trials have shown large and sustained reductions in Lp(a) levels, but cardiovascular outcome benefit has not yet been proven in completed outcome trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Alexander City, Alabama and 243 other locations
- Advanced Cardiovascular LLC — Alexander City, Alabama, United States (Recruiting)
- University of Alabama Birmingham Saint Vincents Birmingham — Birmingham, Alabama, United States (Recruiting)
- Birmingham Clinical Research — Birmingham, Alabama, United States (Recruiting)
- Alliance For Multispecialty Research - Daphne — Daphne, Alabama, United States (Recruiting)
- Eastern Shore Research Institute — Fairhope, Alabama, United States (Recruiting)
- Heart Center Research LLC — Huntsville, Alabama, United States (Recruiting)
- CB Flock Research Corporation — Mobile, Alabama, United States (Recruiting)
- Phoenix Clinical — Phoenix, Arizona, United States (Recruiting)
- Elite Clinical Studies LLC — Phoenix, Arizona, United States (Recruiting)
- Hero Clinical Research — Phoenix, Arizona, United States (Recruiting)
- HonorHealth Research Institute — Scottsdale, Arizona, United States (Recruiting)
- Eclipse Clinical Research — Tucson, Arizona, United States (Recruiting)
- Lynn Institute of the Ozarks — Little Rock, Arkansas, United States (Recruiting)
- National Heart Institute — Beverly Hills, California, United States (Recruiting)
- 310 Clinical Research — Inglewood, California, United States (Recruiting)
- University of California San Diego — La Jolla, California, United States (Recruiting)
- InvivoCure — Los Angeles, California, United States (Recruiting)
- Valley Clinical Trials — Northridge, California, United States (Recruiting)
- Clinical Trials Research - Sacramento — Roseville, California, United States (Recruiting)
- Alliance Clinical Research — San Diego, California, United States (Recruiting)
- Encompass Clinical Research — Spring Valley, California, United States (Recruiting)
- Stanford Health Care — Stanford, California, United States (Recruiting)
- Manshadi Heart Institute — Stockton, California, United States (Recruiting)
- Blue Coast Cardiology — Vista, California, United States (Recruiting)
- Diablo Clinical Research — Walnut Creek, California, United States (Recruiting)
- Focus Clinical Research — West Hills, California, United States (Recruiting)
- Interventional Cardiology Medical Group — West Hills, California, United States (Recruiting)
- UCHealth Memorial Central — Colorado Springs, Colorado, United States (Recruiting)
- South Denver Cardiology Associates — Littleton, Colorado, United States (Recruiting)
- Gandelman Cardiology, PC — Greenwich, Connecticut, United States (Recruiting)
- ClinTrial Hamden — Hamden, Connecticut, United States (Recruiting)
- Chase Medical Research LLC — Waterbury, Connecticut, United States (Recruiting)
- Excel Medical Clinical Trials — Boca Raton, Florida, United States (Recruiting)
- Clearwater Cardiovascular Consultants — Clearwater, Florida, United States (Recruiting)
- Proactive Clinical Research — Fort Lauderdale, Florida, United States (Recruiting)
- Indago Research and Health Center — Hialeah, Florida, United States (Recruiting)
- Elite Cardiac Research Center LLC — Hialeah, Florida, United States (Recruiting)
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (Recruiting)
- East Coast Institute for Research, LLC — Lake City, Florida, United States (Recruiting)
- Columbus Clinical Services LLC — Miami, Florida, United States (Recruiting)
- Kendall South Medical Center — Miami, Florida, United States (Recruiting)
- Inpatient Research Clinic, LLC — Miami Lakes, Florida, United States (Recruiting)
- Panax Clinical Research — Miami Lakes, Florida, United States (Recruiting)
- Eminat, LLC — Miramar, Florida, United States (Recruiting)
- Suncoast Clinical Research Inc — New Port Richey, Florida, United States (Recruiting)
- Ocala Cardiovascular Research — Ocala, Florida, United States (Recruiting)
- Ocala Research Institute, Inc — Ocala, Florida, United States (Recruiting)
- Ormond Beach Clinical Research — Ormond Beach, Florida, United States (Recruiting)
- Baptist Health Care — Pensacola, Florida, United States (Recruiting)
- Denali Health Plant City — Plant City, Florida, United States (Recruiting)
+194 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.