NCT07293260 Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial
| NCT ID | NCT07293260 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Amgen |
| Condition | Cardiovascular Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 406 participants |
| Start Date | 2026-03-23 |
| Primary Completion | 2028-06-15 |
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 406 participants in total. It began in 2026-03-23 with a primary completion date of 2028-06-15.
⚠ 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 of this trial is to evaluate the effect of olpasiran, compared to placebo, on non-calcified plaque (NCP) volume as measured by Coronary Computed Tomography Angiography (CCTA).
Eligibility Criteria
Inclusion Criteria: * Age 35 to ≤ 80 years. * Lp(a) ≥ 200 nmol/L during screening. * Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA. * History of myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or coronary revascularization by percutaneous coronary intervention. Exclusion Criteria: * History of coronary artery bypass graft (CABG). * Moderate to severe renal dysfunction. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN), or total bilirubin (TBL) \> 2 x ULN during screening. * History of hemorrhagic stroke. * History of major bleeding disorder. * Planned cardiac surgery or arterial revascularization. * Severe heart failure. * Current, recent, or planned lipoprotein apheresis. * Previously received ribonucleic acid therapy specifically targeting Lp(a).
Contact & Investigator
MD
STUDY DIRECTOR
Amgen
Frequently Asked Questions
Who can join the NCT07293260 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 80 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 NCT07293260 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 406 participants.
Is NCT07293260 currently recruiting?
Yes, NCT07293260 is actively recruiting participants. Contact the research team at medinfo@amgen.com for enrollment information.
Where is the NCT07293260 trial being conducted?
This trial is being conducted at Bridgeport, United States, Jacksonville, United States, Overland Park, United States, Bowie, United States and 11 additional locations.
Who is sponsoring the NCT07293260 clinical trial?
NCT07293260 is sponsored by Amgen. The principal investigator is MD at Amgen. The trial plans to enroll 406 participants.