EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

Stroke Clinical Trial

— EVOLVE-MI  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05284747
• Other study ID #: 20190184
• Secondary ID: 2021-005272-19
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 26, 2022
• Est. completion date: May 31, 2027

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI]).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6000
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Revascularization
• Infarction
• Myocardial Infarction
• Stroke

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Brazil	Centro de Pesquisa Clinica do Coracao	Aracaju	Sergipe
Brazil	Hospital Madre Teresa	Belo Horizonte	Minas Gerais
Brazil	Hospital Universitário Ciências Médicas de Belo Horizonte	Belo Horizonte	Minas Gerais
Brazil	Instituto de Pesquisa Clínica de Campinas	Campinas	São Paulo
Brazil	Ps Cardiologico de PE - Procape	Casa Forte	Pernambuco
Brazil	Hospital Ruy Azeredo	Ipiranga Goiânia	Goiás
Brazil	Hospital Universitario Sao Francisco na Providencia de Deus	Ipiranga Goiânia	Goiás
Brazil	Cmep-Centro Multidisciplinar Ensino e Pesq	Joinville	Santa Catarina
Brazil	Instituto Cardiovascular de Linhares	Linhares	Espírito Santo
Brazil	Irmandade da Santa Casa de Misericordia de Marilia	Marilia	São Paulo
Brazil	Instituto Atena de Pesquisa Clínica	Natal	Rio Grande Do Norte
Brazil	Hospital do Coracao de Pocos de Caldas CEC servicos medicos	Pocos de Caldas	Minas Gerais
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	Hospital Mãe de Deus	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	Instituto de Cardiologia de Santa Catarina	Praia Comprida, Sao Jose	Santa Catarina
Brazil	Hospital Regional de Presidente Prudente	Presidente Prudente	São Paulo
Brazil	Clínica Silvestre Sante	Rio Branco	Acre
Brazil	Instituto Dante Pazanesse	Sao Paulo	São Paulo
Brazil	Hospital Beneficência Portuguesa	São Paulo	Rio Grande Do Sul
Brazil	Hospital Israelita Albert Einstein	São Paulo
Brazil	Instituto do coracao da Faculdade de Medicina da Universidade de Sao Paulo - InCor	São Paulo
Sweden	Alingsas Lasarett	Alingsas
Sweden	Gavle Sjukhus	Gavle
Sweden	Lanssjukhuset Ryhov	Jonkoping
Sweden	Blekingesjukhuset Karlskrona	Karlskrona
Sweden	Linkoping University Hospital	Linkoping
Sweden	Sunderby Sjukhus	Lulea
Sweden	Skane Universitetssjukhus i Lund	Lund
Sweden	Molndals Sjukhus	Molndahl
Sweden	Vrinnevisjukhuset, Norrkoeping	Norrkoeping
Sweden	Ostersunds sjukhus	Ostersund
Sweden	Sodersjukhuset	Stockholm
Sweden	Sundsvalls Sjukhus	Sundsvall
Sweden	Akademiska Sjukhuset i Uppsala	Uppsala
Sweden	Vastmanlands Sjukhus Vasteras	Vasteras
Sweden	Centrallasarettet Vaxjo	Vaxjo
United States	University of Colorado Hospital	Aurora	Colorado
United States	Ascension Texas Cardiovascular	Austin	Texas
United States	South Shore University Hospital Northwell Health	Bay Shore	New York
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Excel Medical Clinical Trials	Boca Raton	Florida
United States	Saint Lukes Boise Medical Center	Boise	Idaho
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Advanced Heart Care LLC	Bridgewater	New Jersey
United States	Montefiore Medical Center	Bronx	New York
United States	Aultman Hospital	Canton	Ohio
United States	Wellspan Chambersburg Hospital	Chambersburg	Pennsylvania
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	Great Lakes Clinical Trials - Ravenswood	Chicago	Illinois
United States	Jesse Brown Veterans Affairs Medical Center	Chicago	Illinois
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Prisma Upstate and Midlands Greenville Hospital System	Columbia	South Carolina
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	John Muir Health and Cardiovascular Institute	Concord	California
United States	Henry Ford Hospital	Detroit	Michigan
United States	Essentia Health Saint Marys Medical Center	Duluth	Minnesota
United States	Eastern Shore Research Institute	Fairhope	Alabama
United States	Northern Arizona Healthcare Corporation Cardiovascular Institute	Flagstaff	Arizona
United States	University of Florida at Gainesville	Gainesville	Florida
United States	Healthy Heart Cardiology	Grand Rapids	Michigan
United States	Moses H Cone Memorial Hospital	Greensboro	North Carolina
United States	Upstate Cardiology	Greenville	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Hartford Hospital	Hartford	Connecticut
United States	Heart Center Research LLC	Huntsville	Alabama
United States	Ascension Saint Vincent Heart Center	Indianapolis	Indiana
United States	Jackson Heart	Jackson	Mississippi
United States	University of Florida and Shands Hospital	Jacksonville	Florida
United States	Saint Lukes Hospital of Kansas City	Kansas City	Missouri
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Tennova Healthcare-Turkey Creek Medical Center	Knoxville	Tennessee
United States	Ascension Texas Cardiovascular Kyle	Kyle	Texas
United States	Lancaster General Hospital/The Heart Group of Lancaster	Lancaster	Pennsylvania
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	University of California Los Angeles	Los Angeles	California
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California
United States	University of Louisville Health - Jewish Hospital	Louisville	Kentucky
United States	Bon Secours St Marys Hospital Richmond	Midlothian	Virginia
United States	Aurora Saint Lukes Medical Center	Milwaukee	Wisconsin
United States	McLaren Macomb Research Services	Mount Clemens	Michigan
United States	Ascension Saint Thomas Nashville	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York Presbyterian-Weill Cornell Medical Center	New York	New York
United States	Saint Michaels Medical Center	Newark	New Jersey
United States	North Kansas City Hospital	North Kansas City	Missouri
United States	Parkway Cardiology Associates	Oak Ridge	Tennessee
United States	University of California-Irvine	Orange	California
United States	AdventHealth Orlando	Orlando	Florida
United States	Midwest Heart and Vascular Specialists	Overland Park	Kansas
United States	Cardiology Partners Clinical Research Institute	Palm Beach Gardens	Florida
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	Ascension Sacred Heart	Pensacola	Florida
United States	Baptist Health Care	Pensacola	Florida
United States	McLaren Northern Michigan Hospital	Petoskey	Michigan
United States	Hudson Valley Cardiovascular Practice PC	Poughkeepsie	New York
United States	Cardiovascular Research of Knoxville North Knoxville Medical Center	Powell	Tennessee
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Chippenham Hospital	Richmond	Virginia
United States	Reid Physician Associates	Richmond	Indiana
United States	University of Rochester Medical Center	Rochester	New York
United States	Advanced Cardiology Associates	Rochester Hills	Michigan
United States	Clearwater Cardiovascular Consultants	Safety Harbor	Florida
United States	Scottsdale Healthcare at Shea - HonorHealth	Scottsdale	Arizona
United States	Cardiology Associates of Fairfield County PC	Stamford	Connecticut
United States	Richmond University Medical Center	Staten Island	New York
United States	Stony Brook Medicine	Stony Brook	New York
United States	Tampa Cardiovascular Interventions and Research	Tampa	Florida
United States	Pima Heart and Vascular Clinical Research	Tucson	Arizona
United States	Ascension Saint John Bartlesville	Tulsa	Oklahoma
United States	Ascension Saint John Tulsa	Tulsa	Oklahoma
United States	Cardiology Associates of North Mississippi	Tupelo	Mississippi
United States	Kent Hospital	Warwick	Rhode Island
United States	Reading Hospital Tower Health	West Reading	Pennsylvania
United States	Clinical Site Partners Orlando dba Flourish Research	Winter Park	Florida
United States	Genesis Healthcare System	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Colorado Prevention Center

Countries where clinical trial is conducted

United States,  Brazil,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	Total Myocardial Infarctions Events		From Baseline to End of Study (Approximately 3.5 Years)
Secondary	Total Arterial Revascularization Procedures		From Baseline to End of Study (Approximately 3.5 Years)
Secondary	Total Ischemia-driven Coronary Revascularization Procedures		From Baseline to End of Study (Approximately 3.5 Years)
Secondary	Total Ischemic Strokes		From Baseline to End of Study (Approximately 3.5 Years)
Secondary	Time to Cardiovascular Death		From Baseline to End of Study (Approximately 3.5 Years)
Secondary	Time to All-Cause Death		From Baseline to End of Study (Approximately 3.5 Years)

External Links

•   AmgenTrials clinical trials website