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NCT Number: NCT07136012

OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events

The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp[a]).

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

50 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Canberra Hospital, Garran, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥50 years
  • Lp(a)≥ 200 nmol/L during screening
  • Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis

Exclusion criteria

  • Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
  • Prior or planned arterial revascularization
  • History of major bleeding disorder

Treatment and study plan

Olpasiran

Drug

Olpasiran will be administered via SC injection.

Other names: AMG 890

Placebo

Drug

Placebo will be administered via SC injection.

Primary outcomes

  1. Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First

    Time frame: Up to approximately 6.2 years

Secondary outcomes

  1. Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First

    Time frame: Up to approximately 6.2 years

  2. Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First

    Time frame: Up to approximately 6.2 years

  3. Percent Change From Baseline to Week 48 Lp(a) Levels

    Time frame: Baseline and Week 48

  4. Time to Myocardial Infarction

    Time frame: Up to approximately 6.2 years

  5. Time to CHD Death or Myocardial Infarction, Whichever Occurs First

    Time frame: Up to approximately 6.2 years

  6. Time to Urgent Coronary Revascularization

    Time frame: Up to approximately 6.2 years

  7. Time to Coronary Revascularization

    Time frame: Up to approximately 6.2 years

  8. Time to CHD Death

    Time frame: Up to approximately 6.2 years

  9. Time to Cardiovascular Death

    Time frame: Up to approximately 6.2 years

  10. Time to Death by any Cause

    Time frame: Up to approximately 6.2 years

  11. Time to Ischemic Stroke

    Time frame: Up to approximately 6.2 years

  12. Serum Concentration of Olpasiran

    Time frame: Up to Week 48

  13. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 6.2 years

    Including serious adverse events and adverse events leading to discontinuation of investigational product.

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants With Elevated Lipoprotein(a)

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Aug 22, 2025
Registry last updated
Jul 10, 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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