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Cardiovascular DiseasePhase 4EVOLVE-MINCT05284747

EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

A Phase 4 study testing Evolocumab and Routine Lipid Management in people with Cardiovascular Disease and Myocardial Infarction, run by Amgen at 120 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Evolocumab and Routine Lipid Management
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,019 participants
Where
120 sitesin 3 countries
Study dates
26 Oct 2022to 29 May 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

120 sites in 3 countries.

120 sites in 3 countries

United States81 sites

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Ascension Texas Cardiovascular

    Austin, Texas, 78705

  • South Shore University Hospital Northwell Health

    Bay Shore, New York, 11706

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434

  • Saint Lukes Boise Medical Center

    Boise, Idaho, 83712

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Advanced Heart Care LLC

    Bridgewater, New Jersey, 08807

  • Aultman Hospital

    Canton, Ohio, 44710

  • Wellspan Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

  • University of North Carolina Cardiology

    Chapel Hill, North Carolina, 27599

  • Novant Health Heart and Vascular Institute Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Jesse Brown Veterans Affairs Medical Center

    Chicago, Illinois, 60612

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois, 60640

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756

  • Prisma Upstate and Midlands Greenville Hospital System

    Columbia, South Carolina, 29203

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • John Muir Health and Cardiovascular Institute

    Concord, California, 94520

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Essentia Health Saint Marys Medical Center

    Duluth, Minnesota, 55805

  • Eastern Shore Research Institute

    Fairhope, Alabama, 36532

  • Northern Arizona Healthcare Corporation Cardiovascular Institute

    Flagstaff, Arizona, 86001

  • University of Florida at Gainesville

    Gainesville, Florida, 32610

  • Healthy Heart Cardiology

    Grand Rapids, Michigan, 49546

  • Moses H Cone Memorial Hospital

    Greensboro, North Carolina, 27401

  • Upstate Cardiology

    Greenville, South Carolina, 29607

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • Heart Center Research LLC

    Huntsville, Alabama, 35801-4317

  • Ascension Saint Vincent Heart Center

    Indianapolis, Indiana, 46290

  • Jackson Heart

    Jackson, Mississippi, 39216

  • University of Florida and Shands Hospital

    Jacksonville, Florida, 32209

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Saint Lukes Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Tennova Healthcare-Turkey Creek Medical Center

    Knoxville, Tennessee, 37934

  • Ascension Texas Cardiovascular Kyle

    Kyle, Texas, 78640

  • Lancaster General Hospital/The Heart Group of Lancaster

    Lancaster, Pennsylvania, 17603

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • University of California Los Angeles

    Los Angeles, California, 90095

  • University of Louisville Health - Jewish Hospital

    Louisville, Kentucky, 40202

  • Bon Secours St Marys Hospital Richmond

    Midlothian, Virginia, 23114

  • Aurora Saint Lukes Medical Center

    Milwaukee, Wisconsin, 53215

  • McLaren Macomb Research Services

    Mount Clemens, Michigan, 48043

  • Ascension Saint Thomas Nashville

    Nashville, Tennessee, 37205

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-8802

  • New York Presbyterian-Weill Cornell Medical Center

    New York, New York, 10065

  • Saint Michaels Medical Center

    Newark, New Jersey, 07102

  • North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Parkway Cardiology Associates

    Oak Ridge, Tennessee, 37830

  • University of California-Irvine

    Orange, California, 92868

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Midwest Heart and Vascular Specialists

    Overland Park, Kansas, 66211

  • Cardiology Partners Clinical Research Institute

    Palm Beach Gardens, Florida, 33410

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • Baptist Health Care

    Pensacola, Florida, 32501

  • Ascension Sacred Heart

    Pensacola, Florida, 32504

  • McLaren Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Hudson Valley Cardiovascular Practice PC

    Poughkeepsie, New York, 12601

  • Cardiovascular Research of Knoxville North Knoxville Medical Center

    Powell, Tennessee, 37849

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Reid Physician Associates

    Richmond, Indiana, 47374

  • Chippenham Hospital

    Richmond, Virginia, 23225

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Advanced Cardiology Associates

    Rochester Hills, Michigan, 48307

  • Clearwater Cardiovascular Consultants

    Safety Harbor, Florida, 34695

  • Scottsdale Healthcare at Shea - HonorHealth

    Scottsdale, Arizona, 85258

  • Cardiology Associates of Fairfield County PC

    Stamford, Connecticut, 06905

  • Richmond University Medical Center

    Staten Island, New York, 10310

  • Stony Brook Medicine

    Stony Brook, New York, 11794

  • Tampa Cardiovascular Interventions and Research

    Tampa, Florida, 33614

  • Montefiore Medical Center

    The Bronx, New York, 10580

  • Pima Heart and Vascular Clinical Research

    Tucson, Arizona, 85719

  • Ascension Saint John Bartlesville

    Tulsa, Oklahoma, 74104

  • Ascension Saint John Tulsa

    Tulsa, Oklahoma, 74104

  • Cardiology Associates of North Mississippi

    Tupelo, Mississippi, 38801

  • Kent Hospital

    Warwick, Rhode Island, 02886

  • Reading Hospital Tower Health

    West Reading, Pennsylvania, 19611

  • Clinical Site Partners Orlando dba Flourish Research

    Winter Park, Florida, 32789

  • Genesis Healthcare System

    Zanesville, Ohio, 43701

Other trials in United States

Brazil24 sites

  • Centro de Pesquisa Clinica do Coracao

    Aracaju, Sergipe, 49055-530

  • Hospital Madre Teresa

    Belo Horizonte, Minas Gerais, 30140-073

  • Hospital Universitário Ciências Médicas de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30140-073

  • Instituto de Pesquisa Clínica de Campinas

    Campinas, São Paulo, 13060-080

  • Ps Cardiologico de PE - Procape

    Casa Forte, Pernambuco, 52061-540

  • Hospital Ruy Azeredo

    Ipiranga Goiânia, Goiás, 74453-200

  • Hospital Universitario Sao Francisco na Providencia de Deus

    Ipiranga Goiânia, Goiás, 74453-200

  • Cmep-Centro Multidisciplinar Ensino e Pesq

    Joinville, Santa Catarina, 89204-250

  • Instituto Cardiovascular de Linhares

    Linhares, Espírito Santo, 29900010

  • Irmandade da Santa Casa de Misericordia de Marilia

    Marília, São Paulo, 90840-440

  • Instituto Atena de Pesquisa Clínica

    Natal, Rio Grande do Norte, 59020-500

  • Hospital do Coracao de Pocos de Caldas CEC servicos medicos

    Poços de Caldas, Minas Gerais, 37706-106

  • Centro de Pesquisa Clínica Associação Hospitalar Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Instituto de Cardiologia do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90620-001

  • Santa Casa de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90620-001

  • Hospital Mãe de Deus

    Porto Alegre, Rio Grande do Sul, 90840-440

  • Instituto de Cardiologia de Santa Catarina

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

  • Hospital Regional de Presidente Prudente

    Presidente Prudente, São Paulo, 19050-680

  • Clínica Silvestre Sante

    Rio Branco, Acre, 69900785

  • Hospital Beneficência Portuguesa

    São Paulo, Rio Grande do Sul, 01323-900

  • Instituto Dante Pazanesse

    São Paulo, São Paulo, 04012-909

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

    São Paulo, 05403-000

  • Hospital Israelita Albert Einstein

    São Paulo, 05652-900

Other trials in Brazil

Sweden15 sites

  • Alingsas Lasarett

    Alingsås, 441 33

  • Gavle Sjukhus

    Gävle, 801 88

  • Lanssjukhuset Ryhov

    Jönköping, 553 05

  • Blekingesjukhuset Karlskrona

    Karlskrona, 371 85

  • Linkoping University Hospital

    Linköping, 581 85

  • Sunderby Sjukhus

    Luleå, 971 80

  • Skane Universitetssjukhus i Lund

    Lund, 221 85

  • Molndals Sjukhus

    Molndahl, 431 80

  • Vrinnevisjukhuset, Norrkoeping

    Norrköping, 601 82

  • Ostersunds sjukhus

    Östersund, 831 83

  • Sodersjukhuset

    Stockholm, 118 83

  • Sundsvalls Sjukhus

    Sundsvall, 851 86

  • Akademiska Sjukhuset i Uppsala

    Uppsala, 751 85

  • Vastmanlands Sjukhus Vasteras

    Västerås, 721 89

  • Centrallasarettet Vaxjo

    Vaxjo, 351 85

Other trials in Sweden

About this study

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

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]).

Being tested
Evolocumab, Routine Lipid Management
Keywords
Acute Myocardial Infarction, Cardiovascular Disease, Stroke, Coronary revascularization, Evolocumab, STEMI, NSTEMI, Heart Attack, Pragmatic
Medical subject headings
Cardiovascular Diseases, Myocardial Infarction, Stroke, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EvolocumabDrug

    Also called Repatha, AMG 145

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

  • Routine Lipid ManagementDrug

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

Study groups in NCT05284747
Study groupRoleWhat they receive
Evolocumab + Routine Lipid ManagementExperimentalParticipants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
Receives: Drug: Evolocumab; Drug: Routine Lipid Management
Routine Lipid ManagementActive comparatorParticipants will receive routine lipid management per standard of care (SoC).
Receives: Drug: Routine Lipid Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death

    Measured: From Baseline to End of Study (Approximately 3.5 Years)

Secondary outcomes (10)

  1. Percentage Change From Baseline in LDL-C

    Percent LDL-C change from baseline to 12 weeks in a subset of approximately 300 randomly selected participants.

    Measured: From Baseline to Week 12

  2. Percentage Change From Baseline in LDL-C

    Percent LDL-C change from baseline to 52 weeks in a subset of approximately 300 randomly selected participants.

    Measured: From Baseline to Week 52

  3. Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death

    Measured: From Baseline to End of Study (Approximately 3.5 Years)

  4. Time to the First Occurrence of the Composite of Myocardial Infarction, Ischemic Stroke, any Arterial Revascularization Procedure, and All-Cause Death

    Measured: From Baseline to End of Study (Approximately 3.5 Years)

  5. Total Myocardial Infarctions Events

    Measured: From Baseline to End of Study (Approximately 3.5 Years)

  6. Total Arterial Revascularization Procedures

    Measured: From Baseline to End of Study (Approximately 3.5 Years)

  7. Total Ischemia-driven Coronary Revascularization Procedures

    Measured: From Baseline to End of Study (Approximately 3.5 Years)

  8. Total Ischemic Strokes

    Measured: From Baseline to End of Study (Approximately 3.5 Years)

  9. Time to Cardiovascular Death

    Measured: From Baseline to End of Study (Approximately 3.5 Years)

  10. Time to All-Cause Death

    Measured: From Baseline to End of Study (Approximately 3.5 Years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2022
  2. Study start26 Oct 2022
  3. Primary completion29 May 2027 (estimated)
  4. Study completion29 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6,019 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05284747
Sponsor's protocol ID
20190184
Other IDs
2021-005272-19
Acronym
EVOLVE-MI
Status last verified
Oct 2025
First submitted
9 Mar 2022
Last updated
6 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Evolocumab and Routine Lipid Management in people with Cardiovascular Disease and Myocardial Infarction, run by Amgen at 120 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Brazil, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death (time frame: From Baseline to End of Study (Approximately 3.5 Years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05284747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.

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