The trial is taking place at:
P

Palmetto Clinical Research | Summerville, SC

Veeva-enabled site

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

Amgen logo

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:

  • Age: Adult subjects ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex) and meeting lipid criteria
  • 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

  • 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

Trial contacts and locations

852

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems