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Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial

RECRUITINGPhase 3Sponsored by Amgen
Actively Recruiting
PhasePhase 3
SponsorAmgen
Started2026-03-23
Est. completion2028-06-15
Eligibility
Age35 Years – 80 Years
Healthy vol.Accepted
Locations6 sites

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

Age: 35 Years – 80 YearsHealthy volunteers accepted
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).

Conditions2

Cardiovascular DiseaseHeart Disease

Interventions1

Locations6 sites

Bridgeport Hospital
Bridgeport, Connecticut, 06610
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Midwest Heart and Vascular Specialists
Overland Park, Kansas, 66211
Flourish Bowie
Bowie, Maryland, 20715
Montefiore Medical Center - Bronx
Philadelphia, Pennsylvania, 19141

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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