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

Purpose

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]).

Condition

  • Cardiovascular Disease

Eligibility

Eligible Ages
Between 50 Years and 105 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Olpasiran 		Participants will receive subcutaneous (SC) olpasiran.
  • Drug: Olpasiran
    Olpasiran will be administered via SC injection.
    Other names:
    • AMG 890
Placebo Comparator
Placebo 		Participants will receive SC placebo.
  • Drug: Placebo
    Placebo will be administered via SC injection.

Recruiting Locations

University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com