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

  • STATUS
    Recruiting
  • End date
    May 30, 2025
  • participants needed
    12000
  • sponsor
    Amgen
Updated on 22 October 2021
diabetes
stroke
myocardial infarction
infarct
arterial disease

Summary

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.

Details
Condition Coronary Artery Disease, Coronary heart disease, Ischemic Heart Disease, Cardiac Ischemia, Myocardial Ischemia, coronary disease, disease, coronary, coronary heart diseases
Treatment Placebo, Evolocumab
Clinical Study IdentifierNCT03872401
SponsorAmgen
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

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 mol/L)
Evidence of at least one of the following at screening (without prior myocardial infarction or stroke)
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 m
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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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