Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Atherosclerotic Cardiovascular Disease
In brief
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).
Key facts
- Study ID
- NCT05581303
- Run by
- Amgen
- People needed
- 7297
- Starts
- 2022-12-14
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Sydvestjysk Sygehus — Esbjerg, Denmark
- Sanos Gandrup — Gandrup, Denmark
- Herlev Gentofte Hospital — Herlev, Denmark
- Sanos Clinic — Herlev, Denmark
- Regionshospitalet Gødstrup — Herning, Denmark
- Holbaek Sygehus — Holbæk, Denmark
- University of Fredriksberg Hospital — København NV, Denmark
- Amager Hospital — København S, Denmark
- Sjaellands Universitetshospital, Roskilde — Roskilde, Denmark
- Slagelse Sygehus — Slagelse, Denmark
- Svendborg Sygehus — Svendborg, Denmark
- Sanos Vejle — Vejle, Denmark
- Regionshospitalet Viborg — Viborg, Denmark
- Innomedica — Tallinn, Estonia
- Center for Clinical and Basic Research Tallinn — Tallinn, Estonia
- Forschungszentrum Ruhr — Witten, Germany
- General Hospital of Athens Evaggelismos — Athens, Greece
- Athens Naval Hospital — Athens, Greece
- General Hospital of Athens Ippokrateio — Athens, Greece
- Laiko General Hospital — Athens, Greece
- Alexandra Hospital — Athens, Greece
- Attikon Hospital — Athens, Greece
- Konstantopoulio - Agia Olga Hospital of Nea Ionia — Athens, Greece
- Hygeia Hospital — Athens, Greece
- Rigshospitalet — Copenhagen O, Denmark
Full record on ClinicalTrials.gov
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