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

Eligibility: for people ages 18-85 (full criteria)
Location: at Orange, California and other locations
Dates: study started December 2022
completion around December 2026

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:
- 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 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
Orange California 92868 United States
VA Greater Los Angeles Healthcare System
Los Angeles California 90073 United States

Details

Status: in progress, not accepting new patients
Start Date: December 2022
Completion Date: December 2026 (estimated)
Sponsor: Amgen
Links: AmgenTrials clinical trials website
ID: NCT05581303
Phase: Phase 3 research study
Study Type: Interventional
Participants: About 7297 people participating
Last Updated: November 2024