EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

Last updated: November 13, 2024
Sponsor: Amgen
Overall Status: Active - Not Recruiting

Phase

4

Condition

Cardiac Disease

Diabetes Prevention

Heart Disease

Treatment

Routine Lipid Management

Evolocumab

Clinical Study ID

NCT05284747
20190184
2021-005272-19
  • Ages 18-99
  • All Genders

Study 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]).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age greater than or equal to 18 years

  • Hospitalized for primary reason of NSTEMI or STEMI due to presumed atheroscleroticdisease

Exclusion

Exclusion Criteria:

  • Participants requiring invasive hemodynamic and/or vasopressor/inotropic support atthe time of screening

  • Participants with elevated biomarkers of myocardial injury due tosecondary/nonatherosclerotic etiology (eg, sepsis, atrial fibrillation, vasospasm,decompensated heart failure, uncontrolled hypertension, stress inducedcardiomyopathy)

Study Design

Total Participants: 6019
Treatment Group(s): 2
Primary Treatment: Routine Lipid Management
Phase: 4
Study Start date:
October 26, 2022
Estimated Completion Date:
May 29, 2027

Connect with a study center

  • Clínica Silvestre Sante

    Rio Branco, Acre 69900785
    Brazil

    Site Not Available

  • Instituto Cardiovascular de Linhares

    Linhares, Espírito Santo 29900010
    Brazil

    Site Not Available

  • Hospital Ruy Azeredo

    Ipiranga Goiânia, Goiás 74453-200
    Brazil

    Site Not Available

  • Hospital Universitario Sao Francisco na Providencia de Deus

    Ipiranga Goiânia, Goiás 74453-200
    Brazil

    Site Not Available

  • Hospital Madre Teresa

    Belo Horizonte, Minas Gerais 30140-073
    Brazil

    Site Not Available

  • Hospital Universitário Ciências Médicas de Belo Horizonte

    Belo Horizonte, Minas Gerais 30140-073
    Brazil

    Site Not Available

  • Hospital do Coracao de Pocos de Caldas CEC servicos medicos

    Pocos de Caldas, Minas Gerais 37706-106
    Brazil

    Site Not Available

  • Pronto Socorro Cardiologico de Pernambuco PROCAPE

    Casa Forte, Pernambuco 52061-540
    Brazil

    Active - Recruiting

  • Ps Cardiologico de PE - Procape

    Casa Forte, Pernambuco 52061-540
    Brazil

    Site Not Available

  • Instituto Atena de Pesquisa Clínica

    Natal, Rio Grande Do Norte 59020-500
    Brazil

    Site Not Available

  • Centro de Pesquisa Clínica Associação Hospitalar Moinhos de Vento

    Porto Alegre, Rio Grande Do Sul 90035-001
    Brazil

    Site Not Available

  • Hospital Mãe de Deus

    Porto Alegre, Rio Grande Do Sul 90840-440
    Brazil

    Site Not Available

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Site Not Available

  • Instituto de Cardiologia Fundação de Cardiologia ICFUC

    Porto Alegre, Rio Grande Do Sul 90620-001
    Brazil

    Active - Recruiting

  • Instituto de Cardiologia do Rio Grande do Sul

    Porto Alegre, Rio Grande Do Sul 90620-001
    Brazil

    Site Not Available

  • Santa Casa de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90620-001
    Brazil

    Site Not Available

  • Hospital Beneficência Portuguesa

    São Paulo, Rio Grande Do Sul 01323-900
    Brazil

    Site Not Available

  • C-MEP Centro Multidisciplinar de Ensino e Pesquisa

    Joinville, Santa Catarina 89204-250
    Brazil

    Active - Recruiting

  • Cmep-Centro Multidisciplinar Ensino e Pesq

    Joinville, Santa Catarina 89204-250
    Brazil

    Site Not Available

  • Instituto de Cardiologia de Santa Catarina

    Praia Comprida, Sao Jose, Santa Catarina 88103-450
    Brazil

    Site Not Available

  • Centro de Pesquisa Clinica do Coracao

    Aracaju, Sergipe 49055-530
    Brazil

    Site Not Available

  • Centro de Pesquisa Clínica do Coracao

    Aracaju, Sergipe 49055-530
    Brazil

    Active - Recruiting

  • Hospital Universitario Sao Francisco na Providencia de Deus

    Braganca Paulista, São Paulo 12916542
    Brazil

    Site Not Available

  • Instituto de Pesquisa Clínica de Campinas

    Campinas, São Paulo 13060-080
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericordia de Marilia

    Marilia, São Paulo 90840-440
    Brazil

    Site Not Available

  • Hospital Regional de Presidente Prudente

    Presidente Prudente, São Paulo 19050-680
    Brazil

    Site Not Available

  • Instituto Dante Pazanesse

    Sao Paulo, São Paulo 04012-909
    Brazil

    Site Not Available

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

    Sao Paulo, São Paulo 05403-900
    Brazil

    Active - Recruiting

  • Hospital Israelita Albert Einstein

    São Paulo, 05652-900
    Brazil

    Site Not Available

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

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Alingsas Lasarett

    Alingsas, 441 33
    Sweden

    Site Not Available

  • Gavle Sjukhus

    Gavle, 801 88
    Sweden

    Site Not Available

  • Lanssjukhuset Ryhov

    Jonkoping, 553 05
    Sweden

    Site Not Available

  • Blekingesjukhuset Karlskrona

    Karlskrona, 371 85
    Sweden

    Site Not Available

  • Linkoping University Hospital

    Linkoping, 581 85
    Sweden

    Site Not Available

  • Sunderby Sjukhus

    Lulea, 971 80
    Sweden

    Site Not Available

  • Skane Universitetssjukhus i Lund

    Lund, 221 85
    Sweden

    Site Not Available

  • Molndals Sjukhus

    Molndahl, 431 80
    Sweden

    Site Not Available

  • Vrinnevisjukhuset, Norrkoeping

    Norrkoeping, 601 82
    Sweden

    Site Not Available

  • Ostersunds sjukhus

    Ostersund, 831 83
    Sweden

    Site Not Available

  • Gavle Sjukhus

    Sandviken, 811 60
    Sweden

    Site Not Available

  • Sodersjukhuset

    Stockholm, 118 83
    Sweden

    Site Not Available

  • Sundsvalls Sjukhus

    Sundsvall, 851 86
    Sweden

    Site Not Available

  • Akademiska Sjukhuset i Uppsala

    Uppsala, 751 85
    Sweden

    Site Not Available

  • Vastmanlands Sjukhus Vasteras

    Vasteras, 721 89
    Sweden

    Site Not Available

  • Centrallasarettet Vaxjo

    Vaxjo, 351 85
    Sweden

    Site Not Available

  • Uab Heart and Vascular Clinic

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Eastern Shore Research Institute

    Fairhope, Alabama 36532
    United States

    Site Not Available

  • Heart Center Research LLC

    Huntsville, Alabama 35801-4317
    United States

    Site Not Available

  • Northern Arizona Healthcare Corporation Cardiovascular Institute

    Flagstaff, Arizona 86001
    United States

    Site Not Available

  • Scottsdale Healthcare at Shea - HonorHealth

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Pima Heart and Vascular Clinical Research

    Tucson, Arizona 85719
    United States

    Site Not Available

  • John Muir Health and Cardiovascular Institute

    Concord, California 94520
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California 90073
    United States

    Site Not Available

  • University of California-Irvine

    Orange, California 92868
    United States

    Site Not Available

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Bridgeport Hospital

    Bridgeport, Connecticut 06610
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Site Not Available

  • Cardiology Associates of Fairfield County PC

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Excel Medical Clinical Trials

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida 33756
    United States

    Site Not Available

  • University of Florida at Gainesville

    Gainesville, Florida 32610
    United States

    Site Not Available

  • University of Florida and Shands Hospital

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University of Florida at UF Health Jacksonville

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Site Not Available

  • Cardiology Partners Clinical Research Institute

    Palm Beach Gardens, Florida 33410
    United States

    Site Not Available

  • Ascension Sacred Heart

    Pensacola, Florida 32504
    United States

    Site Not Available

  • Baptist Health Care

    Pensacola, Florida 32501
    United States

    Site Not Available

  • Clearwater Cardiovascular Consultants

    Safety Harbor, Florida 34695
    United States

    Site Not Available

  • Tampa Cardiovascular Interventions and Research

    Tampa, Florida 33614
    United States

    Site Not Available

  • Clinical Site Partners Orlando dba Flourish Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Saint Lukes Boise Medical Center

    Boise, Idaho 83712
    United States

    Site Not Available

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Jesse Brown Veterans Affairs Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Ascension Saint Vincent Heart Center

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • Reid Physician Associates

    Richmond, Indiana 47374
    United States

    Site Not Available

  • University of Kansas Hospital

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Midwest Heart and Vascular Specialists

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • University of Louisville Health - Jewish Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • UofL Health - Jewish Hospital

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Healthy Heart Cardiology

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Healthy Heart Cardiology PLC

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Sparrow Clinical Research Institute

    Lansing, Michigan 48912
    United States

    Site Not Available

  • McLaren Macomb Research Services

    Mount Clemens, Michigan 48043
    United States

    Site Not Available

  • McLaren Northern Michigan Hospital

    Petoskey, Michigan 49770
    United States

    Site Not Available

  • Advanced Cardiology Associates

    Rochester Hills, Michigan 48307
    United States

    Site Not Available

  • Rochester Hills

    Rochester Hills, Michigan 48307
    United States

    Active - Recruiting

  • Essentia Health Saint Marys Medical Center

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Jackson Heart

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Cardiology Associates of North Mississippi

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Saint Lukes Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Saint Lukes Hospital of Kansas City

    Missouri City, Missouri 64111
    United States

    Site Not Available

  • North Kansas City Hospital

    North Kansas City, Missouri 64116
    United States

    Site Not Available

  • Advanced Heart Care LLC

    Bridgewater, New Jersey 08807
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Saint Michaels Medical Center

    Newark, New Jersey 07102
    United States

    Site Not Available

  • South Shore University Hospital Northwell Health

    Bay Shore, New York 11706
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10580
    United States

    Site Not Available

  • New York Presbyterian-Weill Cornell Medical Center

    New York, New York 10065
    United States

    Site Not Available

  • Hudson Valley Cardiovascular Practice PC

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Richmond University Medical Center

    Staten Island, New York 10310
    United States

    Site Not Available

  • Stony Brook Medicine

    Stony Brook, New York 11794
    United States

    Site Not Available

  • University of North Carolina Cardiology

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Novant Health Heart and Vascular Institute Presbyterian Medical Center

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Moses H Cone Memorial Hospital

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Duke Cardiology and Cardiovascular of Lumberton

    Lumberton, North Carolina 28358
    United States

    Site Not Available

  • Aultman Hospital

    Canton, Ohio 44710
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Genesis Healthcare System

    Zanesville, Ohio 43701
    United States

    Site Not Available

  • Genesis Heart and Vascular Institute

    Zanesville, Ohio 43701
    United States

    Active - Recruiting

  • Ascension Saint John Bartlesville

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Ascension Saint John Tulsa

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Wellspan Chambersburg Hospital

    Chambersburg, Pennsylvania 17201
    United States

    Site Not Available

  • Lancaster General Hospital/The Heart Group of Lancaster

    Lancaster, Pennsylvania 17603
    United States

    Site Not Available

  • Reading Hospital Tower Health

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Kent Hospital

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Prisma Upstate and Midlands Greenville Hospital System

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Upstate Cardiology

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Tennova Healthcare-Turkey Creek Medical Center

    Knoxville, Tennessee 37934
    United States

    Site Not Available

  • Turkey Creek Medical Center

    Knoxville, Tennessee 37934
    United States

    Active - Recruiting

  • Ascension Saint Thomas Nashville

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232-8802
    United States

    Site Not Available

  • Parkway Cardiology Associates

    Oak Ridge, Tennessee 37830
    United States

    Site Not Available

  • Cardiovascular Research of Knoxville North Knoxville Medical Center

    Powell, Tennessee 37849
    United States

    Site Not Available

  • Ascension Texas Cardiovascular

    Austin, Texas 78705
    United States

    Site Not Available

  • Ascension Texas Cardiovascular Kyle

    Kyle, Texas 78640
    United States

    Site Not Available

  • Bon Secours St Marys Hospital Richmond

    Midlothian, Virginia 23114
    United States

    Site Not Available

  • Chippenham Hospital

    Richmond, Virginia 23225
    United States

    Site Not Available

  • Aurora Saint Lukes Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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