Last updated on April 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Coronary heart disease | Myocardial Ischemia | Ischemic Heart Disease | Cardiac Ischemia | Coronary Artery Disease
  • Age: Between 50 - 79 Years
  • Gender: Male or Female

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 nonhigh-density lipoprotein cholesterol (non-HDL) 120 mg/dL ( 3.1 mmol/L) at screening, or apolipoprotein B 80 mg/dL ( 1.56 mol/L)
  3. Evidence of at least one of the following at screening (without prior myocardial infarction or stroke):
  4. Significant coronary artery disease (CAD) B. Significant atherosclerotic cerebrovascular disease C. Significant peripheral arterial disease D. Diabetes mellitus
  5. 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 m
  • Uncontrolled or recurrent ventricular tachycardia in the absence of an implantable-cardioverter defibrillator.
  • Atrial fibrillation not on anticoagulation therapy (vitamin K antagonist, heparin, low molecular weight heparin, fondaparinux,or non-Vitamin K antagonist oral anticoagulant)
  • Fasting triglycerides 500 mg/dL (5.7 mmol/L) at screening
  • Last measured left-ventricular ejection fraction 30% or New York Heart Association (NYHA) Functional Class III/IV
  • Planned arterial revascularization

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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