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ACTIVE NOT RECRUITING

NCT05284747

PHASE4

EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction \[NSTEMI\] and ST-segment elevation myocardial infarction \[STEMI\]).

Official title: EVOLVE-MI: A Pragmatic Randomized Multicenter Trial of EVOLocumab Administered Very Early to Reduce the Risk of Cardiovascular Events in Patients Hospitalized With Acute Myocardial Infarction

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

6019

Start Date

2022-10-26

Completion Date

2027-05-29

Last Updated

2025-10-06

Healthy Volunteers

Conditions

Cardiovascular Disease Myocardial Infarction Stroke Coronary Revascularization

Interventions

DRUG

Evolocumab

Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection.

DRUG

Routine Lipid Management

Routine lipid management therapies will be administered at the discretion of the investigator per SoC.

Locations (120)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Eastern Shore Research Institute

Fairhope, Alabama, United States

Heart Center Research LLC

Huntsville, Alabama, United States

Northern Arizona Healthcare Corporation Cardiovascular Institute

Flagstaff, Arizona, United States

Scottsdale Healthcare at Shea - HonorHealth

Scottsdale, Arizona, United States

Pima Heart and Vascular Clinical Research

Tucson, Arizona, United States

John Muir Health and Cardiovascular Institute

Concord, California, United States

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

University of California-Irvine

Orange, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Bridgeport Hospital

Bridgeport, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

Cardiology Associates of Fairfield County PC

Stamford, Connecticut, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States

University of Florida at Gainesville

Gainesville, Florida, United States

University of Florida and Shands Hospital

Jacksonville, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Cardiology Partners Clinical Research Institute

Palm Beach Gardens, Florida, United States

Baptist Health Care

Pensacola, Florida, United States

Ascension Sacred Heart

Pensacola, Florida, United States

Clearwater Cardiovascular Consultants

Safety Harbor, Florida, United States

Tampa Cardiovascular Interventions and Research

Tampa, Florida, United States

Clinical Site Partners Orlando dba Flourish Research

Winter Park, Florida, United States

Saint Lukes Boise Medical Center

Boise, Idaho, United States

Jesse Brown Veterans Affairs Medical Center

Chicago, Illinois, United States

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Ascension Saint Vincent Heart Center

Indianapolis, Indiana, United States

Reid Physician Associates

Richmond, Indiana, United States

University of Kansas Hospital

Kansas City, Kansas, United States

Midwest Heart and Vascular Specialists

Overland Park, Kansas, United States

University of Louisville Health - Jewish Hospital

Louisville, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Healthy Heart Cardiology

Grand Rapids, Michigan, United States

Sparrow Clinical Research Institute

Lansing, Michigan, United States

McLaren Macomb Research Services

Mount Clemens, Michigan, United States

McLaren Northern Michigan Hospital

Petoskey, Michigan, United States

Advanced Cardiology Associates

Rochester Hills, Michigan, United States

Essentia Health Saint Marys Medical Center

Duluth, Minnesota, United States

Jackson Heart

Jackson, Mississippi, United States

Cardiology Associates of North Mississippi

Tupelo, Mississippi, United States

Saint Lukes Hospital of Kansas City

Kansas City, Missouri, United States

North Kansas City Hospital

North Kansas City, Missouri, United States

Advanced Heart Care LLC

Bridgewater, New Jersey, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Saint Michaels Medical Center

Newark, New Jersey, United States

South Shore University Hospital Northwell Health

Bay Shore, New York, United States

New York Presbyterian-Weill Cornell Medical Center

New York, New York, United States

Hudson Valley Cardiovascular Practice PC

Poughkeepsie, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Richmond University Medical Center

Staten Island, New York, United States

Stony Brook Medicine

Stony Brook, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of North Carolina Cardiology

Chapel Hill, North Carolina, United States

Novant Health Heart and Vascular Institute Presbyterian Medical Center

Charlotte, North Carolina, United States

Moses H Cone Memorial Hospital

Greensboro, North Carolina, United States

Aultman Hospital

Canton, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Genesis Healthcare System

Zanesville, Ohio, United States

Ascension Saint John Bartlesville

Tulsa, Oklahoma, United States

Ascension Saint John Tulsa

Tulsa, Oklahoma, United States

Wellspan Chambersburg Hospital

Chambersburg, Pennsylvania, United States

Lancaster General Hospital/The Heart Group of Lancaster

Lancaster, Pennsylvania, United States

Reading Hospital Tower Health

West Reading, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Kent Hospital

Warwick, Rhode Island, United States

Prisma Upstate and Midlands Greenville Hospital System

Columbia, South Carolina, United States

Upstate Cardiology

Greenville, South Carolina, United States

Tennova Healthcare-Turkey Creek Medical Center

Knoxville, Tennessee, United States

Ascension Saint Thomas Nashville

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Parkway Cardiology Associates

Oak Ridge, Tennessee, United States

Cardiovascular Research of Knoxville North Knoxville Medical Center

Powell, Tennessee, United States

Ascension Texas Cardiovascular

Austin, Texas, United States

Ascension Texas Cardiovascular Kyle

Kyle, Texas, United States

Bon Secours St Marys Hospital Richmond

Midlothian, Virginia, United States

Chippenham Hospital

Richmond, Virginia, United States

Aurora Saint Lukes Medical Center

Milwaukee, Wisconsin, United States

Clínica Silvestre Sante

Rio Branco, Acre, Brazil

Instituto Cardiovascular de Linhares

Linhares, Espírito Santo, Brazil

Hospital Ruy Azeredo

Ipiranga Goiânia, Goiás, Brazil

Hospital Universitario Sao Francisco na Providencia de Deus

Ipiranga Goiânia, Goiás, Brazil

Hospital Madre Teresa

Belo Horizonte, Minas Gerais, Brazil

Hospital Universitário Ciências Médicas de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Hospital do Coracao de Pocos de Caldas CEC servicos medicos

Poços de Caldas, Minas Gerais, Brazil

Ps Cardiologico de PE - Procape

Casa Forte, Pernambuco, Brazil

Instituto Atena de Pesquisa Clínica

Natal, Rio Grande do Norte, Brazil

Centro de Pesquisa Clínica Associação Hospitalar Moinhos de Vento