EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction
EVOLVE-MI
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
2 other identifiers
interventional
6,019
3 countries
120
Brief 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 \[STEMI\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2022
Longer than P75 for phase_4
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedStudy Start
First participant enrolled
October 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 29, 2027
October 6, 2025
October 1, 2025
4.6 years
March 9, 2022
October 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death
From Baseline to End of Study (Approximately 3.5 Years)
Secondary Outcomes (10)
Percentage Change From Baseline in LDL-C
From Baseline to Week 12
Percentage Change From Baseline in LDL-C
From Baseline to Week 52
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death
From Baseline to End of Study (Approximately 3.5 Years)
Time to the First Occurrence of the Composite of Myocardial Infarction, Ischemic Stroke, any Arterial Revascularization Procedure, and All-Cause Death
From Baseline to End of Study (Approximately 3.5 Years)
Total Myocardial Infarctions Events
From Baseline to End of Study (Approximately 3.5 Years)
- +5 more secondary outcomes
Study Arms (2)
Evolocumab + Routine Lipid Management
EXPERIMENTALParticipants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
Routine Lipid Management
ACTIVE COMPARATORParticipants will receive routine lipid management per standard of care (SoC).
Interventions
Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection.
Routine lipid management therapies will be administered at the discretion of the investigator per SoC.
Eligibility Criteria
You may qualify if:
- Age greater than or equal to 18 years
- Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
- Colorado Prevention Centercollaborator
Study Sites (120)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Eastern Shore Research Institute
Fairhope, Alabama, 36532, United States
Heart Center Research LLC
Huntsville, Alabama, 35801-4317, United States
Northern Arizona Healthcare Corporation Cardiovascular Institute
Flagstaff, Arizona, 86001, United States
Scottsdale Healthcare at Shea - HonorHealth
Scottsdale, Arizona, 85258, United States
Pima Heart and Vascular Clinical Research
Tucson, Arizona, 85719, United States
John Muir Health and Cardiovascular Institute
Concord, California, 94520, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California-Irvine
Orange, California, 92868, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
Cardiology Associates of Fairfield County PC
Stamford, Connecticut, 06905, United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756, United States
University of Florida at Gainesville
Gainesville, Florida, 32610, United States
University of Florida and Shands Hospital
Jacksonville, Florida, 32209, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Cardiology Partners Clinical Research Institute
Palm Beach Gardens, Florida, 33410, United States
Baptist Health Care
Pensacola, Florida, 32501, United States
Ascension Sacred Heart
Pensacola, Florida, 32504, United States
Clearwater Cardiovascular Consultants
Safety Harbor, Florida, 34695, United States
Tampa Cardiovascular Interventions and Research
Tampa, Florida, 33614, United States
Clinical Site Partners Orlando dba Flourish Research
Winter Park, Florida, 32789, United States
Saint Lukes Boise Medical Center
Boise, Idaho, 83712, United States
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, 60612, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Ascension Saint Vincent Heart Center
Indianapolis, Indiana, 46290, United States
Reid Physician Associates
Richmond, Indiana, 47374, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Midwest Heart and Vascular Specialists
Overland Park, Kansas, 66211, United States
University of Louisville Health - Jewish Hospital
Louisville, Kentucky, 40202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Healthy Heart Cardiology
Grand Rapids, Michigan, 49546, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
McLaren Macomb Research Services
Mount Clemens, Michigan, 48043, United States
McLaren Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
Advanced Cardiology Associates
Rochester Hills, Michigan, 48307, United States
Essentia Health Saint Marys Medical Center
Duluth, Minnesota, 55805, United States
Jackson Heart
Jackson, Mississippi, 39216, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, 38801, United States
Saint Lukes Hospital of Kansas City
Kansas City, Missouri, 64111, United States
North Kansas City Hospital
North Kansas City, Missouri, 64116, United States
Advanced Heart Care LLC
Bridgewater, New Jersey, 08807, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Saint Michaels Medical Center
Newark, New Jersey, 07102, United States
South Shore University Hospital Northwell Health
Bay Shore, New York, 11706, United States
New York Presbyterian-Weill Cornell Medical Center
New York, New York, 10065, United States
Hudson Valley Cardiovascular Practice PC
Poughkeepsie, New York, 12601, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Richmond University Medical Center
Staten Island, New York, 10310, United States
Stony Brook Medicine
Stony Brook, New York, 11794, United States
Montefiore Medical Center
The Bronx, New York, 10580, United States
University of North Carolina Cardiology
Chapel Hill, North Carolina, 27599, United States
Novant Health Heart and Vascular Institute Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Moses H Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
Aultman Hospital
Canton, Ohio, 44710, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Genesis Healthcare System
Zanesville, Ohio, 43701, United States
Ascension Saint John Bartlesville
Tulsa, Oklahoma, 74104, United States
Ascension Saint John Tulsa
Tulsa, Oklahoma, 74104, United States
Wellspan Chambersburg Hospital
Chambersburg, Pennsylvania, 17201, United States
Lancaster General Hospital/The Heart Group of Lancaster
Lancaster, Pennsylvania, 17603, United States
Reading Hospital Tower Health
West Reading, Pennsylvania, 19611, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Kent Hospital
Warwick, Rhode Island, 02886, United States
Prisma Upstate and Midlands Greenville Hospital System
Columbia, South Carolina, 29203, United States
Upstate Cardiology
Greenville, South Carolina, 29607, United States
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
Ascension Saint Thomas Nashville
Nashville, Tennessee, 37205, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8802, United States
Parkway Cardiology Associates
Oak Ridge, Tennessee, 37830, United States
Cardiovascular Research of Knoxville North Knoxville Medical Center
Powell, Tennessee, 37849, United States
Ascension Texas Cardiovascular
Austin, Texas, 78705, United States
Ascension Texas Cardiovascular Kyle
Kyle, Texas, 78640, United States
Bon Secours St Marys Hospital Richmond
Midlothian, Virginia, 23114, United States
Chippenham Hospital
Richmond, Virginia, 23225, United States
Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin, 53215, United States
Clínica Silvestre Sante
Rio Branco, Acre, 69900785, Brazil
Instituto Cardiovascular de Linhares
Linhares, Espírito Santo, 29900010, Brazil
Hospital Ruy Azeredo
Ipiranga Goiânia, Goiás, 74453-200, Brazil
Hospital Universitario Sao Francisco na Providencia de Deus
Ipiranga Goiânia, Goiás, 74453-200, Brazil
Hospital Madre Teresa
Belo Horizonte, Minas Gerais, 30140-073, Brazil
Hospital Universitário Ciências Médicas de Belo Horizonte
Belo Horizonte, Minas Gerais, 30140-073, Brazil
Hospital do Coracao de Pocos de Caldas CEC servicos medicos
Poços de Caldas, Minas Gerais, 37706-106, Brazil
Ps Cardiologico de PE - Procape
Casa Forte, Pernambuco, 52061-540, Brazil
Instituto Atena de Pesquisa Clínica
Natal, Rio Grande do Norte, 59020-500, Brazil
Centro de Pesquisa Clínica Associação Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90620-001, Brazil
Santa Casa de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90620-001, Brazil
Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, 90840-440, Brazil
Hospital Beneficência Portuguesa
São Paulo, Rio Grande do Sul, 01323-900, Brazil
Cmep-Centro Multidisciplinar Ensino e Pesq
Joinville, Santa Catarina, 89204-250, Brazil
Instituto de Cardiologia de Santa Catarina
Praia Comprida, Sao Jose, Santa Catarina, 88103-450, Brazil
Centro de Pesquisa Clinica do Coracao
Aracaju, Sergipe, 49055-530, Brazil
Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, 13060-080, Brazil
Irmandade da Santa Casa de Misericordia de Marilia
Marília, São Paulo, 90840-440, Brazil
Hospital Regional de Presidente Prudente
Presidente Prudente, São Paulo, 19050-680, Brazil
Instituto Dante Pazanesse
São Paulo, São Paulo, 04012-909, Brazil
Instituto do coracao da Faculdade de Medicina da Universidade de Sao Paulo - InCor
São Paulo, 05403-000, Brazil
Hospital Israelita Albert Einstein
São Paulo, 05652-900, Brazil
Alingsas Lasarett
Alingsås, 441 33, Sweden
Gavle Sjukhus
Gävle, 801 88, Sweden
Lanssjukhuset Ryhov
Jönköping, 553 05, Sweden
Blekingesjukhuset Karlskrona
Karlskrona, 371 85, Sweden
Linkoping University Hospital
Linköping, 581 85, Sweden
Sunderby Sjukhus
Luleå, 971 80, Sweden
Skane Universitetssjukhus i Lund
Lund, 221 85, Sweden
Molndals Sjukhus
Molndahl, 431 80, Sweden
Vrinnevisjukhuset, Norrkoeping
Norrköping, 601 82, Sweden
Ostersunds sjukhus
Östersund, 831 83, Sweden
Sodersjukhuset
Stockholm, 118 83, Sweden
Sundsvalls Sjukhus
Sundsvall, 851 86, Sweden
Akademiska Sjukhuset i Uppsala
Uppsala, 751 85, Sweden
Centrallasarettet Vaxjo
Vaxjo, 351 85, Sweden
Vastmanlands Sjukhus Vasteras
Västerås, 721 89, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2022
First Posted
March 17, 2022
Study Start
October 26, 2022
Primary Completion (Estimated)
May 29, 2027
Study Completion (Estimated)
May 29, 2027
Last Updated
October 6, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.