Summary

Eligibility
for people ages 50-79 (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

Official Title

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

Keywords

Coronary Heart Disease (CHD), High Cardiovascular Risk, No prior Myocardial Infarction stroke, >= 50 years of age (men), >= 55 years of age (women), lipid-lowering therapy, Heart Diseases, Myocardial Infarction, Coronary Disease, Coronary Artery Disease, Myocardial Ischemia, Infarction, Evolocumab, Evolocumab 140 mg Q2W

Eligibility

You can join if…

Open to people ages 50-79

  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):
    1. 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

You CAN'T join if...

  • 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

Locations

  • Harbor University of California Los Angeles Medical Center
    Torrance California 90502 United States
  • Cardiovascular Research Foundation of Southern California
    Beverly Hills California 90210 United States
  • Westside Medical Associates of Los Angeles
    Beverly Hills California 90211 United States
  • Center for Clinical Trials of Sacramento Inc
    Sacramento California 95823 United States
  • West Coast Research LLC
    Dublin California 94568 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT03872401
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 12301 people participating
Last Updated