EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction
- Conditions
- Coronary RevascularizationCardiovascular DiseaseMyocardial InfarctionStroke
- Interventions
- Drug: Routine Lipid Management
- Registration Number
- NCT05284747
- Lead Sponsor
- Amgen
- 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 \[STEMI\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 6019
- Age greater than or equal to 18 years
- Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Routine Lipid Management Routine Lipid Management Participants will receive routine lipid management per standard of care (SoC). Evolocumab + Routine Lipid Management Routine Lipid Management Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management. Evolocumab + Routine Lipid Management Evolocumab Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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) Percentage Change From Baseline in LDL-C From Baseline to Week 52 Percent LDL-C change from baseline to 52 weeks in a subset of approximately 300 randomly selected participants.
Time to All-Cause Death From Baseline to End of Study (Approximately 3.5 Years) 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) Time to Cardiovascular Death From Baseline to End of Study (Approximately 3.5 Years) Total Ischemia-driven Coronary Revascularization Procedures From Baseline to End of Study (Approximately 3.5 Years)
Trial Locations
- Locations (119)
John Muir Health and Cardiovascular Institute
🇺🇸Concord, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Northern Arizona Healthcare Corporation Cardiovascular Institute
🇺🇸Flagstaff, Arizona, United States
Ascension Sacred Heart
🇺🇸Pensacola, Florida, United States
Great Lakes Clinical Trials - Ravenswood
🇺🇸Chicago, Illinois, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Upstate Cardiology
🇺🇸Greenville, South Carolina, United States
Ps Cardiologico de PE - Procape
🇧🇷Casa Forte, Pernambuco, Brazil
Ascension Saint Thomas Nashville
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Hospital Universitário Ciências Médicas de Belo Horizonte
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Instituto Atena de Pesquisa ClÃnica
🇧🇷Natal, Rio Grande Do Norte, Brazil
Essentia Health Saint Marys Medical Center
🇺🇸Duluth, Minnesota, United States
Instituto Cardiovascular de Linhares
🇧🇷Linhares, EspÃrito Santo, Brazil
Hospital do Coracao de Pocos de Caldas CEC servicos medicos
🇧🇷Pocos de Caldas, Minas Gerais, Brazil
Hospital Madre Teresa
🇧🇷Belo Horizonte, Minas Gerais, Brazil
ClÃnica Silvestre Sante
🇧🇷Rio Branco, Acre, Brazil
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
Centro de Pesquisa ClÃnica Associação Hospitalar Moinhos de Vento
🇧🇷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
Hospital de ClÃnicas 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
University of California Los Angeles
🇺🇸Los Angeles, California, United States
Ascension Saint Vincent Heart Center
🇺🇸Indianapolis, Indiana, United States
North Kansas City Hospital
🇺🇸North Kansas City, Missouri, United States
Reid Physician Associates
🇺🇸Richmond, Indiana, United States
Richmond University Medical Center
🇺🇸Staten Island, New York, United States
Moses H Cone Memorial Hospital
🇺🇸Greensboro, North Carolina, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
South Shore University Hospital Northwell Health
🇺🇸Bay Shore, New York, United States
Novant Health Heart and Vascular Institute Presbyterian Medical Center
🇺🇸Charlotte, North Carolina, United States
Bon Secours St Marys Hospital Richmond
🇺🇸Midlothian, Virginia, United States
Ascension Saint John Bartlesville
🇺🇸Tulsa, Oklahoma, United States
Pima Heart and Vascular Clinical Research
🇺🇸Tucson, Arizona, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Saint Lukes Boise Medical Center
🇺🇸Boise, Idaho, United States
Cardiology Partners Clinical Research Institute
🇺🇸Palm Beach Gardens, Florida, United States
Baptist Health Care
🇺🇸Pensacola, Florida, United States
McLaren Macomb Research Services
🇺🇸Mount Clemens, Michigan, United States
Advanced Cardiology Associates
🇺🇸Rochester Hills, Michigan, United States
Cardiology Associates of Fairfield County PC
🇺🇸Stamford, Connecticut, United States
University of Florida and Shands Hospital
🇺🇸Jacksonville, Florida, United States
Clearwater Cardiovascular Consultants
🇺🇸Safety Harbor, Florida, United States
Scottsdale Healthcare at Shea - HonorHealth
🇺🇸Scottsdale, Arizona, United States
Tennova Healthcare-Turkey Creek Medical Center
🇺🇸Knoxville, Tennessee, United States
Prisma Upstate and Midlands Greenville Hospital System
🇺🇸Columbia, South Carolina, United States
Centro de Pesquisa Clinica do Coracao
🇧🇷Aracaju, Sergipe, Brazil
Cardiovascular Research of Knoxville North Knoxville Medical Center
🇺🇸Powell, Tennessee, United States
Cardiology Associates of North Mississippi
🇺🇸Tupelo, Mississippi, United States
Jackson Heart
🇺🇸Jackson, Mississippi, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Hospital Israelita Albert Einstein
🇧🇷São Paulo, Brazil
Hospital Ruy Azeredo
🇧🇷Ipiranga Goiânia, Goiás, Brazil
Healthy Heart Cardiology
🇺🇸Grand Rapids, Michigan, United States
McLaren Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
Parkway Cardiology Associates
🇺🇸Oak Ridge, Tennessee, United States
Instituto do coracao da Faculdade de Medicina da Universidade de Sao Paulo - InCor
🇧🇷São Paulo, Brazil
Saint Michaels Medical Center
🇺🇸Newark, New Jersey, United States
Hospital Universitario Sao Francisco na Providencia de Deus
🇧🇷Ipiranga Goiânia, Goiás, Brazil
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Aurora Saint Lukes Medical Center
🇺🇸Milwaukee, Wisconsin, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Tampa Cardiovascular Interventions and Research
🇺🇸Tampa, Florida, United States
Heart Center Research LLC
🇺🇸Huntsville, Alabama, United States
Eastern Shore Research Institute
🇺🇸Fairhope, Alabama, United States
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
University of California-Irvine
🇺🇸Orange, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Clinical Site Partners Orlando dba Flourish Research
🇺🇸Winter Park, Florida, United States
Jesse Brown Veterans Affairs Medical Center
🇺🇸Chicago, Illinois, United States
Midwest Heart and Vascular Specialists
🇺🇸Overland Park, Kansas, United States
Advanced Heart Care LLC
🇺🇸Bridgewater, New Jersey, United States
Hudson Valley Cardiovascular Practice PC
🇺🇸Poughkeepsie, New York, United States
New York Presbyterian-Weill Cornell Medical Center
🇺🇸New York, New York, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
Stony Brook Medicine
🇺🇸Stony Brook, New York, United States
Genesis Healthcare System
🇺🇸Zanesville, Ohio, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Reading Hospital Tower Health
🇺🇸West Reading, Pennsylvania, United States
Ascension Saint John Tulsa
🇺🇸Tulsa, Oklahoma, United States
Wellspan Chambersburg Hospital
🇺🇸Chambersburg, Pennsylvania, United States
Kent Hospital
🇺🇸Warwick, Rhode Island, United States
Ascension Texas Cardiovascular Kyle
🇺🇸Kyle, Texas, United States
Instituto de Cardiologia de Santa Catarina
🇧🇷Praia Comprida, Sao Jose, Santa Catarina, Brazil
Cmep-Centro Multidisciplinar Ensino e Pesq
🇧🇷Joinville, Santa Catarina, Brazil
Irmandade da Santa Casa de Misericordia de Marilia
🇧🇷Marilia, São Paulo, Brazil
Instituto Dante Pazanesse
🇧🇷Sao Paulo, São Paulo, Brazil
Instituto de Pesquisa ClÃnica de Campinas
🇧🇷Campinas, São Paulo, Brazil
Gavle Sjukhus
🇸🇪Gavle, Sweden
Alingsas Lasarett
🇸🇪Alingsas, Sweden
Hospital Regional de Presidente Prudente
🇧🇷Presidente Prudente, São Paulo, Brazil
Sunderby Sjukhus
🇸🇪Lulea, Sweden
Blekingesjukhuset Karlskrona
🇸🇪Karlskrona, Sweden
Lanssjukhuset Ryhov
🇸🇪Jonkoping, Sweden
Linkoping University Hospital
🇸🇪Linkoping, Sweden
Vrinnevisjukhuset, Norrkoeping
🇸🇪Norrkoeping, Sweden
Skane Universitetssjukhus i Lund
🇸🇪Lund, Sweden
Molndals Sjukhus
🇸🇪Molndahl, Sweden
Ostersunds sjukhus
🇸🇪Ostersund, Sweden
Sodersjukhuset
🇸🇪Stockholm, Sweden
Akademiska Sjukhuset i Uppsala
🇸🇪Uppsala, Sweden
Vastmanlands Sjukhus Vasteras
🇸🇪Vasteras, Sweden
Centrallasarettet Vaxjo
🇸🇪Vaxjo, Sweden
Sundsvalls Sjukhus
🇸🇪Sundsvall, Sweden
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Saint Lukes Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Ascension Texas Cardiovascular
🇺🇸Austin, Texas, United States
Chippenham Hospital
🇺🇸Richmond, Virginia, United States
University of Louisville Health - Jewish Hospital
🇺🇸Louisville, Kentucky, United States
University of North Carolina Cardiology
🇺🇸Chapel Hill, North Carolina, United States
University of Florida at Gainesville
🇺🇸Gainesville, Florida, United States
Lancaster General Hospital/The Heart Group of Lancaster
🇺🇸Lancaster, Pennsylvania, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States