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

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Cardiovascular Disease

Treatments: Drug: Olpasiran; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07136012

20230222

Details and patient eligibility

About

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]).

Enrollment: 11,000 estimated patients

Sex: All

Ages: 50 to 105 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11,000 participants in 2 patient groups, including a placebo group

Olpasiran

Experimental group

Description:

Participants will receive subcutaneous (SC) olpasiran.

Treatment:

Drug: Olpasiran

Placebo

Placebo Comparator group

Description:

Participants will receive SC placebo.

Treatment:

Drug: Placebo