Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

• Status: Recruiting
• Trial end date: 2025-05-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Evolocumab

Criteria

Inclusion criteria:

1. Age: Adult subjects ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex) and meeting lipid criteria

2. Low-density lipoprotein cholesterol (LDL-C) ≥ 90 mg/dL (≥ 2.3 mmol/L) or non-high-density lipoprotein cholesterol (non-HDL) ≥ 120 mg/dL (≥ 3.1 mmol/L), or apolipoprotein B ≥ 80 mg/dL (≥ 1.56 µmol/L)

3. Evidence of at least one of the following at screening (without prior myocardial infarction or stroke):

A. Significant coronary artery disease (CAD) B. Significant atherosclerotic cerebrovascular disease C. Significant peripheral arterial disease D. Diabetes mellitus

4. At least 1 high-risk feature

Exclusion criteria

• MI or stroke prior to randomization

• Coronary artery bypass grafting (CABG) ˂ 3 months prior to screening

• Estimated glomerular filtration rate (eGFR) ˂ 15 mL/min/1.73 m²

• Uncontrolled or recurrent ventricular tachycardia in the absence of an implantable-cardioverter defibrillator.

• Atrial fibrillation or atrial flutter not on anticoagulation therapy (vitamin K antagonist, heparin, low molecular weight heparin, fondaparinux,or non-Vitamin K antagonist oral anticoagulant)

• Triglycerides ≥ 500 mg/dL (5.7 mmol/L) measured up to 3 months prior to screening. The most recent results must be used.

• Last measured left-ventricular ejection fraction ˂ 30% or New York Heart Association (NYHA) Functional Class III/IV

• Planned arterial revascularization