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NCT03872401

PHASE3

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

Sponsor: Amgen

View on ClinicalTrials.gov

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.

Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

Key Details

Gender

All

Age Range

50 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

12301

Start Date

2019-06-11

Completion Date

2025-07-25

Last Updated

2026-06-25

Healthy Volunteers

Conditions

Coronary Heart Disease (CHD)

Interventions

DRUG

Evolocumab

Administered subcutaneously using an autoinjector pen.

DRUG

Placebo

Administered subcutaneously using an autoinjector pen.

Inclusion criteria: * 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). 3.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: 1. percutaneous coronary intervention (PCI) of 2 or more vessels, including branch arteries, 2. PCI or coronary artery bypass grafting (CABG) with residual 50% stenosis in a separate, unrevascularized vessel, or 3. 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). * At least 1 coronary, carotid, or peripheral artery residual stenosis of ≥50% in a participant with diabetes meeting inclusion criterion (D above). * LDL-C ≥130 mg/dL (≥3.36 mmol/L), OR non-HDL-C ≥160 mg/dL (≥4.14 mmol/L), OR apolipoprotein B ≥120 mg/dL (2.3 µmol/L) if available. * Lipoprotein (a) \>125 nmol/L (50 mg/dL). * Known familial hypercholesterolemia. * Family history of premature coronary artery disease defined as an MI or CABG in the participant's father or brother at age \<55 years or an MI or CABG in the participant's mother or sister at age \<60 years. * High sensitive c-reactive protein (hsCRP) ≥3.0 mg/L in the absence of an acute illness. * Current tobacco use. -≥65 years of age. * Menopause before 40 years of age. * eGFR 15 to \<45 mL/min/1.73 m\^2. * Coronary artery calcification score ≥300 in a participant without a coronary revascularization prior to randomization. Exclusion criteria * 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.

Locations (852)

North Alabama Research Center LLC

Athens, Alabama, United States

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

Cohen Medical Associates PA

Delray Beach, Florida, United States

Jellinger and Lerman MD PA dba The Center for Diabetes and Endocrine Care

Fort Lauderdale, Florida, United States

George E Platt MD

Green Cove Springs, Florida, United States

Research Physicians Network Alliance

Hollywood, Florida, United States

University of Florida and Shands Hospital

Jacksonville, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

First Coast Cardiovascular Institute PA

Jacksonville, Florida, United States

Baptist Health Research Institute

Jacksonville Beach, Florida, United States

Gad Research Center

Miami, Florida, United States

Cardiovascular Research Center of South Florida

Miami, Florida, United States

Ocala Research Institute, Inc

Ocala, Florida, United States

Cardiology Consultants

Pensacola, Florida, United States

Charlotte Heart Group Research Center

Port Charlotte, Florida, United States

Intercoastal Medical Group

Sarasota, Florida, United States

Cardiovascular Center of Sarasota

Sarasota, Florida, United States

Florida Cardiology Group

Winter Park, Florida, United States

The Florida Lipid Institute

Winter Park, Florida, United States

NSC Research

Johns Creek, Georgia, United States

Kootenai Heart Clinics, LLC

Coeur d'Alene, Idaho, United States

Northwest Heart Clinical Research LLC

Arlington Heights, Illinois, United States

Deaconess Clinic

Evansville, Indiana, United States

LaPorte County Institute for Clinical Research

Michigan City, Indiana, United States

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

The University of Iowa College of Public Health

Iowa City, Iowa, United States

MercyOne Iowa Heart Center

West Des Moines, Iowa, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

Saint Elizabeth Covington

Covington, Kentucky, United States

The Research Group of Lexington LLC

Lexington, Kentucky, United States

Alexandria Cardiology Clinic

Alexandria, Louisiana, United States

Grace Research LLC

Bossier City, Louisiana, United States

Horizon Research Group of Opelousas LLC

Eunice, Louisiana, United States

Louisiana Heart Center

Hammond, Louisiana, United States

Barnum Medical Research

Natchitoches, Louisiana, United States

Grace Research LLC

Shreveport, Louisiana, United States

Louisiana Heart Center

Slidell, Louisiana, United States

Northern Light Eastern Maine Medical Center

Bangor, Maine, United States

Southern Maine Health Care

Biddeford, Maine, United States

Maryland Cardiovascular Specialists

Baltimore, Maryland, United States

Metropolitan Cardiovascular Consultants LLC

Beltsville, Maryland, United States

TidalHealth Peninsula Regional, Inc

Salisbury, Maryland, United States

Brigham and Womens Hospital

Boston, Massachusetts, United States

Charles River Medical Associates

Framingham, Massachusetts, United States

East Mountain Medical Associates, PC

Great Barrington, Massachusetts, United States

Baystate Health Center

Springfield, Massachusetts, United States

Ahmed Arif Medical Research Center LLC

Flint, Michigan, United States

Healthy Heart Cardiology

Grand Rapids, Michigan, United States

Rajendra H Mehta, MD, PC

Jackson, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

Saint Marys Medical Center

Duluth, Minnesota, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Saint Cloud Hospital

Saint Cloud, Minnesota, United States

HealthEast Medical Research Institute

Saint Paul, Minnesota, United States

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, United States

Mercy Research

St Louis, Missouri, United States

Great Falls Clinic LLP

Great Falls, Montana, United States

Bryan Heart

Lincoln, Nebraska, United States

Nebraska Western Iowa Health Care System

Omaha, Nebraska, United States

Palm Research Center Inc

Las Vegas, Nevada, United States

Virtua Health, Inc.

Voorhees Township, New Jersey, United States

Healthwise Medical Associates

Brooklyn, New York, United States

Trinity Medical Western New York, PC

Cheektowaga, New York, United States

WMCHealth Heart and Vascular Institute Kingston Division of Cardiology

Kingston, New York, United States

Northwell Health Physician Partners Cardiology

Manhasset, New York, United States

North Shore Diabetes and Endocrine Associates

New Hyde Park, New York, United States

Northwell Health Lenox Hill Heart and Vascular

New York, New York, United States

Hudson Valley Cardiovascular Physicians PC

Poughkeepsie, New York, United States

Saratoga Clinical Research, LLC

Saratoga Springs, New York, United States

Division of Cardiovascular Research at Peconic Bay Medical Center

Southampton, New York, United States

Asheville Cardiology Associates

Asheville, North Carolina, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Novant Health Heart and Vascular Institute

Charlotte, North Carolina, United States

Moses H Cone Memorial Hospital

Greensboro, North Carolina, United States

Crossroads Clinical Research Inc

Mooresville, North Carolina, United States

Piedmont Medical Group Research of Rocky Mount

Rocky Mount, North Carolina, United States

PMG Research of Salisbury

Salisbury, North Carolina, United States

And 752 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (852)