Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV)

Amgen

Status and phase: Active, not recruiting; Phase 3

Conditions: Coronary Heart Disease (CHD)

Treatments: Drug: Evolocumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03872401

20170625

2018-004565-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 12,301 patients

Sex: All

Ages: 50 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

12,301 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive placebo subcutaneous injection once every 2 weeks (Q2W).

Treatment:

Drug: Placebo

Evolocumab 140 mg Q2W

Experimental group

Description:

Participants will receive 140 mg evolocumab by subcutaneous injection Q2W.

Treatment:

Drug: Evolocumab