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

Phase 3Active Not RecruitingNCT05581303

Amgen7,297 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

7,297

Conditions

Atherosclerotic Cardiovascular Disease

Interventions

PlaceboDRUG

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

OlpasiranDRUG

Olpasiran given by subcutaneous injection Q12W.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (737)

Outcomes

Primary Outcomes

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