Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
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
- Coronary Heart Disease (CHD)
Eligibility
- Eligible Ages
- Between 50 Years and 79 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Arm | Description | Assigned Intervention |
---|---|---|
Placebo Comparator Placebo |
Participants will receive placebo subcutaneous injection once every 2 weeks (Q2W). |
|
Experimental Evolocumab 140 mg Q2W |
Participants will receive 140 mg evolocumab by subcutaneous injection Q2W. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Amgen