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NCT Number: NCT05581303

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Investigaciones Clinicas Bahia Blanca, Bahía Blanca, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo

Drug

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

Olpasiran

Drug

Olpasiran given by subcutaneous injection Q12W.

Primary outcomes

  1. Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first

    Time frame: Approximately 5 years

Secondary outcomes

  1. Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first

    Time frame: Approximately 5 years

  2. Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first

    Time frame: Approximately 5 years

  3. Percent change from baseline to Week 48 in Lipoprotein(a)

    Time frame: Baseline and Week 48

  4. Time to myocardial infarction

    Time frame: Approximately 5 years

  5. Time to CHD death or myocardial infarction, whichever occurs first

    Time frame: Approximately 5 years

  6. Time to urgent coronary revascularization

    Time frame: Approximately 5 years

  7. Time to coronary revascularization

    Time frame: Approximately 5 years

  8. Time to CHD death

    Time frame: Approximately 5 years

  9. Time to cardiovascular death

    Time frame: Approximately 5 years

  10. Time to death by any cause

    Time frame: Approximately 5 years

  11. Time to ischemic stroke

    Time frame: Approximately 5 years

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Oct 14, 2022
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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