EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

NCT ID: NCT05284747

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

6019 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-26

Study Completion Date

2027-05-29

Brief Summary

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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 \[STEMI\]).

Detailed Description

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Conditions

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Cardiovascular Disease Myocardial Infarction Stroke Coronary Revascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evolocumab + Routine Lipid Management

Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type DRUG

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

Routine Lipid Management

Intervention Type DRUG

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

Routine Lipid Management

Participants will receive routine lipid management per standard of care (SoC).

Group Type ACTIVE_COMPARATOR

Routine Lipid Management

Intervention Type DRUG

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

Interventions

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Evolocumab

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

Intervention Type DRUG

Routine Lipid Management

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

Intervention Type DRUG

Other Intervention Names

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Repatha AMG 145

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to 18 years
* Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease

Exclusion Criteria

* Participants requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening
* Participants with elevated biomarkers of myocardial injury due to secondary/nonatherosclerotic etiology (eg, sepsis, atrial fibrillation, vasospasm, decompensated heart failure, uncontrolled hypertension, stress induced cardiomyopathy)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Colorado Prevention Center

OTHER

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Eastern Shore Research Institute

Fairhope, Alabama, United States

Site Status

Heart Center Research LLC

Huntsville, Alabama, United States

Site Status

Northern Arizona Healthcare Corporation Cardiovascular Institute

Flagstaff, Arizona, United States

Site Status

Scottsdale Healthcare at Shea - HonorHealth

Scottsdale, Arizona, United States

Site Status

Pima Heart and Vascular Clinical Research

Tucson, Arizona, United States

Site Status

John Muir Health and Cardiovascular Institute

Concord, California, United States

Site Status

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

Site Status

University of California Los Angeles

Los Angeles, California, United States

Site Status

University of California-Irvine

Orange, California, United States

Site Status

University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Bridgeport Hospital

Bridgeport, Connecticut, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

Cardiology Associates of Fairfield County PC

Stamford, Connecticut, United States

Site Status

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Site Status

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States

Site Status

University of Florida at Gainesville

Gainesville, Florida, United States

Site Status

University of Florida and Shands Hospital

Jacksonville, Florida, United States

Site Status

AdventHealth Orlando

Orlando, Florida, United States

Site Status

Cardiology Partners Clinical Research Institute

Palm Beach Gardens, Florida, United States

Site Status

Baptist Health Care

Pensacola, Florida, United States

Site Status

Ascension Sacred Heart

Pensacola, Florida, United States

Site Status

Clearwater Cardiovascular Consultants

Safety Harbor, Florida, United States

Site Status

Tampa Cardiovascular Interventions and Research

Tampa, Florida, United States

Site Status

Clinical Site Partners Orlando dba Flourish Research

Winter Park, Florida, United States

Site Status

Saint Lukes Boise Medical Center

Boise, Idaho, United States

Site Status

Jesse Brown Veterans Affairs Medical Center

Chicago, Illinois, United States

Site Status

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States

Site Status

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Site Status

Ascension Saint Vincent Heart Center

Indianapolis, Indiana, United States

Site Status

Reid Physician Associates

Richmond, Indiana, United States

Site Status

University of Kansas Hospital

Kansas City, Kansas, United States

Site Status

Midwest Heart and Vascular Specialists

Overland Park, Kansas, United States

Site Status

University of Louisville Health - Jewish Hospital

Louisville, Kentucky, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Healthy Heart Cardiology

Grand Rapids, Michigan, United States

Site Status

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Site Status

McLaren Macomb Research Services

Mount Clemens, Michigan, United States

Site Status

McLaren Northern Michigan Hospital

Petoskey, Michigan, United States

Site Status

Advanced Cardiology Associates

Rochester Hills, Michigan, United States

Site Status

Essentia Health Saint Marys Medical Center

Duluth, Minnesota, United States

Site Status

Jackson Heart

Jackson, Mississippi, United States

Site Status

Cardiology Associates of North Mississippi

Tupelo, Mississippi, United States

Site Status

Saint Lukes Hospital of Kansas City

Kansas City, Missouri, United States

Site Status

North Kansas City Hospital

North Kansas City, Missouri, United States

Site Status

Advanced Heart Care LLC

Bridgewater, New Jersey, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

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Saint Michaels Medical Center

Newark, New Jersey, United States

Site Status

South Shore University Hospital Northwell Health

Bay Shore, New York, United States

Site Status

New York Presbyterian-Weill Cornell Medical Center

New York, New York, United States

Site Status

Hudson Valley Cardiovascular Practice PC

Poughkeepsie, New York, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Richmond University Medical Center

Staten Island, New York, United States

Site Status

Stony Brook Medicine

Stony Brook, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

University of North Carolina Cardiology

Chapel Hill, North Carolina, United States

Site Status

Novant Health Heart and Vascular Institute Presbyterian Medical Center

Charlotte, North Carolina, United States

Site Status

Moses H Cone Memorial Hospital

Greensboro, North Carolina, United States

Site Status

Aultman Hospital

Canton, Ohio, United States

Site Status

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Genesis Healthcare System

Zanesville, Ohio, United States

Site Status

Ascension Saint John Bartlesville

Tulsa, Oklahoma, United States

Site Status

Ascension Saint John Tulsa

Tulsa, Oklahoma, United States

Site Status

Wellspan Chambersburg Hospital

Chambersburg, Pennsylvania, United States

Site Status

Lancaster General Hospital/The Heart Group of Lancaster

Lancaster, Pennsylvania, United States

Site Status

Reading Hospital Tower Health

West Reading, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Kent Hospital

Warwick, Rhode Island, United States

Site Status

Prisma Upstate and Midlands Greenville Hospital System

Columbia, South Carolina, United States

Site Status

Upstate Cardiology

Greenville, South Carolina, United States

Site Status

Tennova Healthcare-Turkey Creek Medical Center

Knoxville, Tennessee, United States

Site Status

Ascension Saint Thomas Nashville

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Parkway Cardiology Associates

Oak Ridge, Tennessee, United States

Site Status

Cardiovascular Research of Knoxville North Knoxville Medical Center

Powell, Tennessee, United States

Site Status

Ascension Texas Cardiovascular

Austin, Texas, United States

Site Status

Ascension Texas Cardiovascular Kyle

Kyle, Texas, United States

Site Status

Bon Secours St Marys Hospital Richmond

Midlothian, Virginia, United States

Site Status

Chippenham Hospital

Richmond, Virginia, United States

Site Status

Aurora Saint Lukes Medical Center

Milwaukee, Wisconsin, United States

Site Status

Clínica Silvestre Sante

Rio Branco, Acre, Brazil

Site Status

Instituto Cardiovascular de Linhares

Linhares, Espírito Santo, Brazil

Site Status

Hospital Ruy Azeredo

Ipiranga Goiânia, Goiás, Brazil

Site Status

Hospital Universitario Sao Francisco na Providencia de Deus

Ipiranga Goiânia, Goiás, Brazil

Site Status

Hospital Madre Teresa

Belo Horizonte, Minas Gerais, Brazil

Site Status

Hospital Universitário Ciências Médicas de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Site Status

Hospital do Coracao de Pocos de Caldas CEC servicos medicos

Poços de Caldas, Minas Gerais, Brazil

Site Status

Ps Cardiologico de PE - Procape

Casa Forte, Pernambuco, Brazil

Site Status

Instituto Atena de Pesquisa Clínica

Natal, Rio Grande do Norte, Brazil

Site Status

Centro de Pesquisa Clínica Associação Hospitalar Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

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Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

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Santa Casa de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

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Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, Brazil

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Hospital Beneficência Portuguesa

São Paulo, Rio Grande do Sul, Brazil

Site Status

Cmep-Centro Multidisciplinar Ensino e Pesq

Joinville, Santa Catarina, Brazil

Site Status

Instituto de Cardiologia de Santa Catarina

Praia Comprida, Sao Jose, Santa Catarina, Brazil

Site Status

Centro de Pesquisa Clinica do Coracao

Aracaju, Sergipe, Brazil

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Instituto de Pesquisa Clínica de Campinas

Campinas, São Paulo, Brazil

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Irmandade da Santa Casa de Misericordia de Marilia

Marília, São Paulo, Brazil

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Hospital Regional de Presidente Prudente

Presidente Prudente, São Paulo, Brazil

Site Status

Instituto Dante Pazanesse

São Paulo, São Paulo, Brazil

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Instituto do coracao da Faculdade de Medicina da Universidade de Sao Paulo - InCor

São Paulo, , Brazil

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Hospital Israelita Albert Einstein

São Paulo, , Brazil

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Alingsas Lasarett

Alingsås, , Sweden

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Gavle Sjukhus

Gävle, , Sweden

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Lanssjukhuset Ryhov

Jönköping, , Sweden

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Blekingesjukhuset Karlskrona

Karlskrona, , Sweden

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Linkoping University Hospital

Linköping, , Sweden

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Sunderby Sjukhus

Luleå, , Sweden

Site Status

Skane Universitetssjukhus i Lund

Lund, , Sweden

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Molndals Sjukhus

Molndahl, , Sweden

Site Status

Vrinnevisjukhuset, Norrkoeping

Norrköping, , Sweden

Site Status

Ostersunds sjukhus

Östersund, , Sweden

Site Status

Sodersjukhuset

Stockholm, , Sweden

Site Status

Sundsvalls Sjukhus

Sundsvall, , Sweden

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Akademiska Sjukhuset i Uppsala

Uppsala, , Sweden

Site Status

Centrallasarettet Vaxjo

Vaxjo, , Sweden

Site Status

Vastmanlands Sjukhus Vasteras

Västerås, , Sweden

Site Status

Countries

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United States Brazil Sweden

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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2021-005272-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20190184

Identifier Type: -

Identifier Source: org_study_id

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