This study is in progress, not accepting new patients

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 Santa Monica, California and other locations
Dates
study started
completion around

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 Los Angeles
    Santa Monica California 90404 United States
  • National Heart Institute
    Beverly Hills California 90211 United States
  • Vitality Clinical Research
    Beverly Hills California 90211 United States
  • Med Partners, Inc dba Premiere Medical Center, Inc
    Toluca Lake California 91602 United States
  • VA Greater Los Angeles Healthcare System
    Los Angeles California 90073 United States
  • Overlook Medical Center
    Summit New Jersey 91010 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website Sign up for this study
ID
NCT05581303
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 7297 people participating
Last Updated