Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial

NCT05581303 · tracked via the Priya Life Science USA tracker

Sponsor

Amgen

Phase

Phase 3

Started

2022-12-14

Last updated

2026-02-27

Condition(s) studied

Atherosclerotic Cardiovascular Disease

Investigational drug(s) / intervention(s)

PlaceboOlpasiran

Placebo: Placebo given by subcutaneous injection once every 12 weeks (Q12W).

Olpasiran: Olpasiran given by subcutaneous injection Q12W.

Study summary

The primary objective of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: * Age 18 to ≤ 85 years * Lp(a) ≥ 200 nmol/L during screening * History of ASCVD as evidenced by history of either: * Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or * Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor. Exclusion Criteria: * 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)

Primary outcome measure(s)

Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first — Approximately 5 years

Trial sites (737)

Facility	City	Region
Ascension Saint Vincents Birmingham	Birmingham	Alabama
Grandview Medical Center Affinity Cardiovascular Specialists, LLC	Birmingham	Alabama
Heart Center Research LLC	Huntsville	Alabama
Mobile Heart Specialists PC	Mobile	Alabama
Alaska Cardiovascular Research Foundation	Anchorage	Alaska
Elite Clinical Studies LLC	Phoenix	Arizona
HonorHealth Research and Innovation Institute	Scottsdale	Arizona
National Heart Institute	Beverly Hills	California
Vitality Clinical Research	Beverly Hills	California
University of California San Diego	La Jolla	California
VA Greater Los Angeles Healthcare System	Los Angeles	California
University of California Irvine	Orange	California
University of California Los Angeles	Santa Monica	California
Manshadi Heart Institute	Stockton	California
Med Partners, Inc dba Premiere Medical Center, Inc	Toluca Lake	California
UCHealth Memorial Central	Colorado Springs	Colorado
Cardiology Associates of Fairfield County PC	Stamford	Connecticut
MedStar Clinical Research	Washington D.C.	District of Columbia
Excel Medical Clinical Trials	Boca Raton	Florida
Bay Area Cardiology	Brandon	Florida
Clearwater Cardiovascular Consultants	Clearwater	Florida
Cardiology Associates Research LLC	Daytona Beach	Florida
Jellinger and Lerman MD PA dba The Center for Diabetes and Endocrine Care	Fort Lauderdale	Florida
Elite Cardiac Research Center LLC	Hialeah	Florida
East Coast Institute for Research, LLC	Jacksonville	Florida
Westside Center for Clinical Research	Jacksonville	Florida
University of Florida	Jacksonville	Florida
East Coast Institute for Research LLC	Jacksonville	Florida
Jacksonville Center for Clinical Research	Jacksonville	Florida
Advanced Research for Health Improvement, LLC	Naples	Florida
Ocala Cardiovascular Research	Ocala	Florida
AdventHealth Medical Group Cardiology at Orlando	Orlando	Florida
East Coast Institute for Research, LLC	Saint Augustine	Florida
Saint Johns Center for Clinical Research	Saint Augustine	Florida
Cardiovascular Center of Sarasota	Sarasota	Florida
Care Access - Tampa	Tampa	Florida
Piedmont Healthcare	Atlanta	Georgia
Morehouse School of Medicine	Atlanta	Georgia
Northeast Georgia Medical Center Wisteria Building	Cumming	Georgia
NSC Research	Johns Creek	Georgia

+ 697 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05581303 on ClinicalTrials.gov ↗ ← All trials in the USA