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

Phase 3RecruitingNCT07136012

Amgen11,000 enrolled

Overview

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\[a\]).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

11,000

Conditions

Cardiovascular Disease

Interventions

OlpasiranDRUG

Olpasiran will be administered via SC injection.

PlaceboDRUG

Placebo will be administered via SC injection.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 105 Years

Medical Language ↔ Plain English

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

Locations (215)

Outcomes

Primary Outcomes

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