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

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)

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

At least 1 high-risk feature

Exclusion criteria

1. MI or stroke prior to randomization
2. Coronary artery bypass grafting (CABG) ˂ 3 months prior to screening
3. Estimated glomerular filtration rate (eGFR) ˂ 15 mL/min/1.73 m²
4. Uncontrolled or recurrent ventricular tachycardia in the absence of an implantable-cardioverter defibrillator.
5. 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)
6. Triglycerides ≥ 500 mg/dL (5.7 mmol/L) measured up to 3 months prior to screening. The most recent results must be used.
7. Last measured left-ventricular ejection fraction ˂ 30% or New York Heart Association (NYHA) Functional Class III/IV
8. Planned arterial revascularization