Purpose

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.

Condition

Eligibility

Eligible Ages
Between 50 Years and 79 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo
Participants will receive placebo subcutaneous injection once every 2 weeks (Q2W) for a minimum of 4 years.
  • Drug: Placebo
    Administered subcutaneously using an autoinjector pen.
Experimental
Evolocumab 140 mg Q2W
Participants will receive 140 mg evolocumab by subcutaneous injection once every 2 weeks for a minimum of 4 years.
  • Drug: Evolocumab
    Administered subcutaneously using an autoinjector pen.
    Other names:
    • AMG 145
    • Repatha

Recruiting Locations

The University of Kansas Medical Center
Kansas City, Kansas 66160-7601

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.