Overview

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