Vesalius-CV: An Investigation On Lowering Your LDL Cholesterol
Sponsored by AMGEN, 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.
The study is the first to investigate long-term outcomes in this population with Repatha for a minimum of four years. The safety and efficacy of Repatha has not been established for this use. Named after the legendary scientist Andreas Vesalius, who was one of the first to accurately depict the anatomy and function of the heart, this study is an important addition to PROFICIO (Program to Reduce LDL-C and cardiovascular Outcomes Following Inhibition of PCSK9 In different pOpulations), the growing clinical program for Repatha.
How to Participate in the Vesalius-CV Study?
Inclusion Criteria
- Age: Adult subjects ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex);
- 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) at screening, 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): Significant coronary artery disease (CAD); Significant atherosclerotic cerebrovascular disease; Significant peripheral arterial disease; or, Diabetes mellitus; and,
- 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
- Atrial fibrillation not on anticoagulation therapy
- Uncontrolled hypertension (sitting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) at screening
- 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
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