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

Completed · Phase 3 · Has a placebo group

Conditions studied: Coronary Heart Disease (CHD)

In brief

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.

Key facts

Study ID

NCT03872401

Run by

Amgen

People needed

12301

Starts

2019-06-11

Expected to finish

2025-07-25

Last updated by the study team

2026-06-25

Who can join

Age: 50 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: Adult participants ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex) and meeting lipid criteria.
• Lipid Criteria: Low-density lipoprotein cholesterol (LDL-C) ≥ 90 mg/dL (≥ 2.3 mmol/L) or non high-density lipoprotein cholesterol (non-HDL)-C ≥ 120 mg/dL (≥ 3.1 mmol/L), or apolipoprotein B ≥ 80 mg/dL (≥ 1.56 µmol/L).
• Diagnostic evidence of at least one of the following (A-D) at screening:
• A.Significant coronary artery disease (CAD) meeting at least 1 of the following criteria:
• History of coronary revascularization with multi-vessel coronary disease as evidenced by any of the following:
• percutaneous coronary intervention (PCI) of 2 or more vessels, including branch arteries,
• PCI or coronary artery bypass grafting (CABG) with residual 50% stenosis in a separate, unrevascularized vessel, or
• multi-vessel CABG 5 years or more prior to screening.
• Significant coronary disease without prior revascularization as evidenced by either a ≥70% stenosis of at least 1 coronary artery, ≥50% stenosis of 2 or more coronary arteries, or ≥50% stenosis of the left main coronary artery.
• known coronary artery calcium score ≥100 in participants without a coronary artery revascularization prior to randomization.
• B. Significant atherosclerotic cerebrovascular disease meeting at least 1 of the following criteria:
• prior transient ischemic attack with ≥50% carotid stenosis.
• internal or external carotid artery stenosis of ≥70% or 2 or more ≥50% stenoses.
• prior internal or external carotid artery revascularization.
• C. Significant peripheral arterial disease meeting at least 1 of the following criteria:
• ≥50% stenosis in a limb artery.
• history of abdominal aorta treatment (percutaneous and surgical) due to atherosclerotic disease.
• ankle brachial index (ABI) <0.85.
• D. Diabetes mellitus with at least 1 of the following:
• known microvascular disease, defined by diabetic nephropathy or treated retinopathy. Diabetic nephropathy defined as persistent microalbuminuria (urinary albumin to creatinine ratio ≥30mg/g) and/or persistent estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m\^2 that is not reversible due to an acute illness.
• chronic daily treatment with an intermediate or long-acting insulin.
• diabetes diagnosis ≥10 years ago.
• At least 1 of the following 1 high-risk criteria (most recent lab values within 6 months prior to screening, as applicable):
• Polyvascular disease, defined as coronary, carotid, or peripheral artery stenosis ≥50% in a second distinct vascular location in a participant with coronary, cerebral or peripheral arterial disease (A, B, or C above).
• Presence of either diabetes mellitus or metabolic syndrome in a participant with coronary, cerebral, or peripheral artery disease (A, B, or C above).

You may not qualify if…

• MI or stroke prior to randomization.
• CABG ˂ 3 months prior to screening.
• eGFR ˂ 15 mL/min/1.73 m\^2.
• 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.

Where it is running

• Cardiovascular Associates — Birmingham, Alabama, United States
• Heart Center Research LLC — Huntsville, Alabama, United States
• Mobile Heart Specialists PC — Mobile, Alabama, United States
• Arkansas Cardiology — Little Rock, Arkansas, United States
• Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States
• Cardiovascular Research Foundation of Southern California — Beverly Hills, California, United States
• Westside Medical Associates of Los Angeles — Beverly Hills, California, United States
• West Coast Research LLC — Dublin, California, United States
• Desert Oasis Healthcare Medical Group — Palm Springs, California, United States
• Covigilant Research, LLC — Riverside, California, United States
• Sierra Clinical Research — Roseville, California, United States
• Center for Clinical Trials of Sacramento Inc — Sacramento, California, United States
• Harbor University of California Los Angeles Medical Center — Torrance, California, United States
• Optumcare Colorado Springs LLC — Colorado Springs, Colorado, United States
• University of Colorado Memorial Health System — Colorado Springs, Colorado, United States
• New West Physicians — Golden, Colorado, United States
• South Denver Cardiology Associates — Littleton, Colorado, United States
• Cardiology Associates of Fairfield County, PC — Stamford, Connecticut, United States
• Excel Medical Clinical Trials — Boca Raton, Florida, United States
• Bay Area Cardiology — Brandon, Florida, United States
• Nature Coast Clinical Research LLC — Crystal River, Florida, United States
• Daytona Heart Group — Daytona Beach, Florida, United States
• Cardiology Research Associates — Daytona Beach, Florida, United States
• Complete Health Research — DeLand, Florida, United States
• North Alabama Research Center LLC — Athens, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.