EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction
NCT ID: NCT05284747
Last Updated: 2025-10-06
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE4
6019 participants
INTERVENTIONAL
2022-10-26
2027-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
Evolocumab
Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection.
Routine Lipid Management
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).
Routine Lipid Management
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.
Routine Lipid Management
Routine lipid management therapies will be administered at the discretion of the investigator per SoC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease
Exclusion Criteria
* 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)
18 Years
99 Years
ALL
No
Sponsors
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Colorado Prevention Center
OTHER
Amgen
INDUSTRY
Responsible Party
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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
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
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Santa Casa de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Beneficência Portuguesa
São Paulo, Rio Grande do Sul, Brazil
Cmep-Centro Multidisciplinar Ensino e Pesq
Joinville, Santa Catarina, Brazil
Instituto de Cardiologia de Santa Catarina
Praia Comprida, Sao Jose, Santa Catarina, Brazil
Centro de Pesquisa Clinica do Coracao
Aracaju, Sergipe, Brazil
Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, Brazil
Irmandade da Santa Casa de Misericordia de Marilia
Marília, São Paulo, Brazil
Hospital Regional de Presidente Prudente
Presidente Prudente, São Paulo, Brazil
Instituto Dante Pazanesse
São Paulo, São Paulo, Brazil
Instituto do coracao da Faculdade de Medicina da Universidade de Sao Paulo - InCor
São Paulo, , Brazil
Hospital Israelita Albert Einstein
São Paulo, , Brazil
Alingsas Lasarett
Alingsås, , Sweden
Gavle Sjukhus
Gävle, , Sweden
Lanssjukhuset Ryhov
Jönköping, , Sweden
Blekingesjukhuset Karlskrona
Karlskrona, , Sweden
Linkoping University Hospital
Linköping, , Sweden
Sunderby Sjukhus
Luleå, , Sweden
Skane Universitetssjukhus i Lund
Lund, , Sweden
Molndals Sjukhus
Molndahl, , Sweden
Vrinnevisjukhuset, Norrkoeping
Norrköping, , Sweden
Ostersunds sjukhus
Östersund, , Sweden
Sodersjukhuset
Stockholm, , Sweden
Sundsvalls Sjukhus
Sundsvall, , Sweden
Akademiska Sjukhuset i Uppsala
Uppsala, , Sweden
Centrallasarettet Vaxjo
Vaxjo, , Sweden
Vastmanlands Sjukhus Vasteras
Västerås, , Sweden
Countries
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Related Links
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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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