Overview

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.

Principal investigator

Ayotunde Dokun
Internal Medicine

Eligibility 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
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For Referring Providers

Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.

Contact the study coordinator

Devona Chun-Furlong
Not currently recruiting, contact if interested.