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

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]).

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Stroke; Cardiovascular Disease; Coronary Revascularization
• Intervention / Treatment: Drug: Evolocumab; Drug: Routine Lipid Management

• Study Type: Interventional
• Enrollment (Estimated): 6000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• Brazil
  • São Paulo, Brazil, 05652-900
    • Recruiting
    • Hospital Israelita Albert Einstein
  • Acre
    • Rio Branco, Acre, Brazil, 69900785
      • Recruiting
      • Clínica Silvestre Sante
  • Espírito Santo
    • Linhares, Espírito Santo, Brazil, 29900010
      • Recruiting
      • Instituto Cardiovascular de Linhares
  • Goiás
    • Ipiranga Goiânia, Goiás, Brazil, 74453-200
      • Recruiting
      • Hospital Ruy Azeredo
    • Ipiranga Goiânia, Goiás, Brazil, 74453-200
      • Recruiting
      • Hospital Universitario Sao Francisco na Providencia de Deus
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30140-073
      • Recruiting
      • Hospital Universitário Ciências Médicas de Belo Horizonte
    • Belo Horizonte, Minas Gerais, Brazil, 30140-073
      • Recruiting
      • Hospital Madre Teresa
    • Pocos de Caldas, Minas Gerais, Brazil, 37706-106
      • Recruiting
      • Hospital do Coracao de Pocos de Caldas CEC servicos medicos
  • Pernambuco
    • Casa Forte, Pernambuco, Brazil, 52061-540
      • Recruiting
      • Ps Cardiologico de PE - Procape
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59020-500
      • Recruiting
      • Instituto Atena de Pesquisa Clínica
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Recruiting
      • Hospital de Clínicas de Porto Alegre
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-001
      • Recruiting
      • Instituto de Cardiologia do Rio Grande do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
      • Recruiting
      • Centro de Pesquisa Clínica Associação Hospitalar Moinhos de Vento
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-001
      • Recruiting
      • Santa Casa de Porto Alegre
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90840-440
      • Recruiting
      • Hospital Mae de Deus
    • São Paulo, Rio Grande Do Sul, Brazil, 01323-900
      • Recruiting
      • Hospital Beneficência Portuguesa
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89204-250
      • Recruiting
      • Cmep-Centro Multidisciplinar Ensino e Pesq
    • Praia Comprida, Sao Jose, Santa Catarina, Brazil, 88103-450
      • Recruiting
      • Instituto de Cardiologia de Santa Catarina
  • Sergipe
    • Aracaju, Sergipe, Brazil, 49055-530
      • Recruiting
      • Centro de Pesquisa Clinica do Coracao
  • São Paulo
    • Campinas, São Paulo, Brazil, 13060-080
      • Recruiting
      • Instituto de Pesquisa Clínica de Campinas
    • Marilia, São Paulo, Brazil, 90840-440
      • Recruiting
      • Irmandade da Santa Casa de Misericordia de Marilia
    • Presidente Prudente, São Paulo, Brazil, 19050-680
      • Recruiting
      • Hospital Regional de Presidente Prudente
    • Sao Paulo, São Paulo, Brazil, 04012-909
      • Recruiting
      • Instituto Dante Pazanesse
    • Sao Paulo, São Paulo, Brazil, 05403-900
      • Recruiting
      • Instituto do coracao da Faculdade de Medicina da Universidade de Sao Paulo - InCor
• Sweden
  • Alingsas, Sweden, 441 33
    • Recruiting
    • Alingsas Lasarett
  • Gavle, Sweden, 801 88
    • Recruiting
    • Gävle Sjukhus
  • Jonkoping, Sweden, 553 05
    • Recruiting
    • Lanssjukhuset Ryhov
  • Karlskrona, Sweden, 371 85
    • Recruiting
    • Blekingesjukhuset Karlskrona
  • Linkoping, Sweden, 581 85
    • Recruiting
    • Linkoping University Hospital
  • Lulea, Sweden, 971 80
    • Recruiting
    • Sunderby Sjukhus
  • Lund, Sweden, 221 85
    • Recruiting
    • Skane Universitetssjukhus i Lund
  • Molndahl, Sweden, 431 80
    • Recruiting
    • Molndals Sjukhus
  • Norrkoeping, Sweden, 601 82
    • Recruiting
    • Vrinnevisjukhuset, Norrkoeping
  • Ostersund, Sweden, 831 83
    • Recruiting
    • Östersunds Sjukhus
  • Stockholm, Sweden, 118 83
    • Recruiting
    • Sodersjukhuset
  • Sundsvall, Sweden, 851 86
    • Recruiting
    • Sundsvalls Sjukhus
  • Uppsala, Sweden, 751 85
    • Recruiting
    • Akademiska Sjukhuset i Uppsala
  • Vasteras, Sweden, 721 89
    • Recruiting
    • Västmanlands Sjukhus Västerås
  • Vaxjo, Sweden, 351 85
    • Recruiting
    • Centrallasarettet Vaxjo
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
    • Fairhope, Alabama, United States, 36532
      • Recruiting
      • Eastern Shore Research Institute
    • Huntsville, Alabama, United States, 35801-4317
      • Recruiting
      • Heart Center Research LLC
  • Arizona
    • Flagstaff, Arizona, United States, 86001
      • Recruiting
      • Northern Arizona Healthcare Corporation Cardiovascular Institute
    • Scottsdale, Arizona, United States, 85258
      • Recruiting
      • Scottsdale Healthcare at Shea - HonorHealth
    • Tucson, Arizona, United States, 85719
      • Recruiting
      • Pima Heart and Vascular Clinical Research
  • California
    • Concord, California, United States, 94520
      • Recruiting
      • John Muir Health and Cardiovascular Institute
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California Los Angeles
    • Los Angeles, California, United States, 90073
      • Recruiting
      • VA Greater Los Angeles Healthcare System
    • Orange, California, United States, 92868
      • Recruiting
      • University of California-Irvine
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Recruiting
      • Bridgeport Hospital
    • Hartford, Connecticut, United States, 06102
      • Recruiting
      • Hartford Hospital
    • Stamford, Connecticut, United States, 06905
      • Recruiting
      • Cardiology Associates of Fairfield County PC
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Recruiting
      • Excel Medical Clinical Trials
    • Clearwater, Florida, United States, 33756
      • Recruiting
      • Clearwater Cardiovascular Consultants
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida at Gainesville
    • Jacksonville, Florida, United States, 32209
      • Recruiting
      • University of Florida and Shands Hospital
    • Orlando, Florida, United States, 32803
      • Recruiting
      • AdventHealth Orlando
    • Palm Beach Gardens, Florida, United States, 33410
      • Recruiting
      • Cardiology Partners Clinical Research Institute
    • Pensacola, Florida, United States, 32504
      • Recruiting
      • Ascension Sacred Heart
    • Pensacola, Florida, United States, 32501
      • Recruiting
      • Baptist Health Care
    • Safety Harbor, Florida, United States, 34695
      • Recruiting
      • Clearwater Cardiovascular Consultants
    • Tampa, Florida, United States, 33614
      • Recruiting
      • Tampa Cardiovascular Interventions and Research
    • Winter Park, Florida, United States, 32789
      • Recruiting
      • Clinical Site Partners Orlando dba Flourish Research
  • Idaho
    • Boise, Idaho, United States, 83712
      • Recruiting
      • Saint Lukes Boise Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Jesse Brown Veterans Affairs Medical Center
    • Chicago, Illinois, United States, 60640
      • Recruiting
      • Great Lakes Clinical Trials - Ravenswood
    • Park Ridge, Illinois, United States, 60068
      • Recruiting
      • Advocate Lutheran General Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Recruiting
      • Ascension Saint Vincent Heart Center
    • Richmond, Indiana, United States, 47374
      • Recruiting
      • Reid Physician Associates
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Hospital
    • Overland Park, Kansas, United States, 66211
      • Recruiting
      • Midwest Heart and Vascular Specialists
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville Health - Jewish Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • Healthy Heart Cardiology
    • Lansing, Michigan, United States, 48912
      • Completed
      • Sparrow Clinical Research Institute
    • Mount Clemens, Michigan, United States, 48043
      • Recruiting
      • McLaren Macomb Research Services
    • Petoskey, Michigan, United States, 49770
      • Recruiting
      • McLaren Northern Michigan Hospital
    • Rochester Hills, Michigan, United States, 48307
      • Recruiting
      • Advanced Cardiology Associates
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Recruiting
      • Essentia Health Saint Marys Medical Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • Jackson Heart
    • Tupelo, Mississippi, United States, 38801
      • Recruiting
      • Cardiology Associates of North Mississippi
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Saint Lukes Hospital of Kansas City
    • North Kansas City, Missouri, United States, 64116
      • Recruiting
      • North Kansas City Hospital
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Completed
      • Advanced Heart Care LLC
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Hackensack University Medical Center
    • Newark, New Jersey, United States, 07102
      • Recruiting
      • Saint Michaels Medical Center
  • New York
    • Bay Shore, New York, United States, 11706
      • Recruiting
      • South Shore University Hospital Northwell Health
    • Bronx, New York, United States, 10580
      • Recruiting
      • Montefiore Medical Center
    • New York, New York, United States, 10065
      • Recruiting
      • New York Presbyterian-Weill Cornell Medical Center
    • Poughkeepsie, New York, United States, 12601
      • Recruiting
      • Hudson Valley Cardiovascular Practice PC
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center
    • Staten Island, New York, United States, 10310
      • Recruiting
      • Richmond University Medical Center
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook Medicine
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina Cardiology
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Novant Health Heart and Vascular Institute Presbyterian Medical Center
    • Greensboro, North Carolina, United States, 27401
      • Recruiting
      • Moses H Cone Memorial Hospital
  • Ohio
    • Canton, Ohio, United States, 44710
      • Recruiting
      • Aultman Hospital
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
    • Zanesville, Ohio, United States, 43701
      • Recruiting
      • Genesis Healthcare System
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Recruiting
      • Ascension Saint John Bartlesville
    • Tulsa, Oklahoma, United States, 74104
      • Recruiting
      • Ascension Saint John Tulsa
  • Pennsylvania
    • Chambersburg, Pennsylvania, United States, 17201
      • Recruiting
      • Wellspan Chambersburg Hospital
    • Lancaster, Pennsylvania, United States, 17603
      • Recruiting
      • Lancaster General Hospital/The Heart Group of Lancaster
    • West Reading, Pennsylvania, United States, 19611
      • Recruiting
      • Reading Hospital Tower Health
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
    • Warwick, Rhode Island, United States, 02886
      • Recruiting
      • Kent Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Recruiting
      • Prisma Upstate and Midlands Greenville Hospital System
    • Greenville, South Carolina, United States, 29607
      • Recruiting
      • Upstate Cardiology
  • Tennessee
    • Knoxville, Tennessee, United States, 37934
      • Recruiting
      • Tennova Healthcare-Turkey Creek Medical Center
    • Nashville, Tennessee, United States, 37205
      • Recruiting
      • Ascension Saint Thomas Nashville
    • Nashville, Tennessee, United States, 37232-8802
      • Recruiting
      • Vanderbilt University Medical Center
    • Oak Ridge, Tennessee, United States, 37830
      • Recruiting
      • Parkway Cardiology Associates
    • Powell, Tennessee, United States, 37849
      • Recruiting
      • Cardiovascular Research of Knoxville North Knoxville Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Ascension Texas Cardiovascular
    • Kyle, Texas, United States, 78640
      • Recruiting
      • Ascension Texas Cardiovascular Kyle
  • Virginia
    • Midlothian, Virginia, United States, 23114
      • Recruiting
      • Bon Secours St Marys Hospital Richmond
    • Richmond, Virginia, United States, 23225
      • Recruiting
      • Chippenham Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Recruiting
      • Aurora Saint Lukes Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evolocumab + Routine Lipid Management; Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.	Drug: Evolocumab; Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection.; Other Names: Repatha; AMG 145; Drug: Routine Lipid Management; Routine lipid management therapies will be administered at the discretion of the investigator per SoC.
Active Comparator: Routine Lipid Management; Participants will receive routine lipid management per standard of care (SoC).	Drug: Routine Lipid Management; Routine lipid management therapies will be administered at the discretion of the investigator per SoC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Total Arterial Revascularization Procedures		From Baseline to End of Study (Approximately 3.5 Years)
Total Ischemic Strokes		From Baseline to End of Study (Approximately 3.5 Years)
Time to Cardiovascular Death		From Baseline to End of Study (Approximately 3.5 Years)
Time to All-Cause Death		From Baseline to End of Study (Approximately 3.5 Years)
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.	From Baseline to Week 12
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.	From Baseline to Week 52
Total Ischemia-driven Coronary Revascularization Procedures		From Baseline to End of Study (Approximately 3.5 Years)

Collaborators and Investigators

• Sponsor: Amgen
• Collaborators: Colorado Prevention Center
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; Stroke; STEMI; Cardiovascular Disease; NSTEMI; Heart Attack; Coronary revascularization; Evolocumab; Pragmatic
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Cardiovascular Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Protease Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Serine Proteinase Inhibitors; PCSK9 Inhibitors; Evolocumab
• Other Study ID Numbers: 20190184; 2021-005272-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No