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

a study on Cardiovascular Disease Atherosclerosis Peripheral Artery Disease

Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

The primary objective of this study 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).

Official 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)

Keywords

Atherosclerotic Cardiovascular Disease, ASCVD, AMG 890, Olpasiran, Cardiovascular Diseases, Atherosclerosis

Eligibility

You can join if…

Open to people ages 18-85

  • Age 18 to ≤ 85 years
  • Lp(a)≥ 200 nmol/L during screening
  • History of ASCVD as evidenced by history of either:

You CAN'T join 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)

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • VA Greater Los Angeles Healthcare System accepting new patients
    Los Angeles California 90073 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT05581303
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 6000 study participants
Last Updated
Contact us about this trial