Clinical trial NCT05284747: EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Cardiovascular Disease
Myocardial Infarction
Stroke
Coronary Revascularization
Keywords: Acute Myocardial Infarction
Cardiovascular Disease
Stroke
Coronary revascularization
Evolocumab
STEMI
NSTEMI
Heart Attack
Pragmatic
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Colorado Prevention Center
First posted: 2022-03-17
Enrollment: 6019
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[STEMI\]).


Eligibility criteria: 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)

Primary outcomes:
measure: Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death
timeFrame: From Baseline to End of Study (Approximately 3.5 Years)
Secondary outcomes:
measure: Percentage Change From Baseline in LDL-C
timeFrame: From Baseline to Week 12
measure: Percentage Change From Baseline in LDL-C
timeFrame: From Baseline to Week 52
measure: Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death
timeFrame: From Baseline to End of Study (Approximately 3.5 Years)
measure: Time to the First Occurrence of the Composite of Myocardial Infarction, Ischemic Stroke, any Arterial Revascularization Procedure, and All-Cause Death
timeFrame: From Baseline to End of Study (Approximately 3.5 Years)
measure: Total Myocardial Infarctions Events
timeFrame: From Baseline to End of Study (Approximately 3.5 Years)
measure: Total Arterial Revascularization Procedures
timeFrame: From Baseline to End of Study (Approximately 3.5 Years)
measure: Total Ischemia-driven Coronary Revascularization Procedures
timeFrame: From Baseline to End of Study (Approximately 3.5 Years)
measure: Total Ischemic Strokes
timeFrame: From Baseline to End of Study (Approximately 3.5 Years)
measure: Time to Cardiovascular Death
timeFrame: From Baseline to End of Study (Approximately 3.5 Years)
measure: Time to All-Cause Death
timeFrame: From Baseline to End of Study (Approximately 3.5 Years)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Fairhope
country: United States
facility: Eastern Shore Research Institute
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research LLC
state: Alabama
city: Flagstaff
country: United States
facility: Northern Arizona Healthcare Corporation Cardiovascular Institute
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare at Shea - HonorHealth
state: Arizona
city: Tucson
country: United States
facility: Pima Heart and Vascular Clinical Research
state: Arizona
city: Concord
country: United States
facility: John Muir Health and Cardiovascular Institute
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Orange
country: United States
facility: University of California-Irvine
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Stamford
country: United States
facility: Cardiology Associates of Fairfield County PC
state: Connecticut
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Gainesville
country: United States
facility: University of Florida at Gainesville
state: Florida
city: Jacksonville
country: United States
facility: University of Florida and Shands Hospital
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Palm Beach Gardens
country: United States
facility: Cardiology Partners Clinical Research Institute
state: Florida
city: Pensacola
country: United States
facility: Baptist Health Care
state: Florida
city: Pensacola
country: United States
facility: Ascension Sacred Heart
state: Florida
city: Safety Harbor
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Tampa
country: United States
facility: Tampa Cardiovascular Interventions and Research
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners Orlando dba Flourish Research
state: Florida
city: Boise
country: United States
facility: Saint Lukes Boise Medical Center
state: Idaho
city: Chicago
country: United States
facility: Jesse Brown Veterans Affairs Medical Center
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Ravenswood
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Ascension Saint Vincent Heart Center
state: Indiana
city: Richmond
country: United States
facility: Reid Physician Associates
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Overland Park
country: United States
facility: Midwest Heart and Vascular Specialists
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Health - Jewish Hospital
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Healthy Heart Cardiology
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Mount Clemens
country: United States
facility: McLaren Macomb Research Services
state: Michigan
city: Petoskey
country: United States
facility: McLaren Northern Michigan Hospital
state: Michigan
city: Rochester Hills
country: United States
facility: Advanced Cardiology Associates
state: Michigan
city: Duluth
country: United States
facility: Essentia Health Saint Marys Medical Center
state: Minnesota
city: Jackson
country: United States
facility: Jackson Heart
state: Mississippi
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Kansas City
country: United States
facility: Saint Lukes Hospital of Kansas City
state: Missouri
city: North Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Bridgewater
country: United States
facility: Advanced Heart Care LLC
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Newark
country: United States
facility: Saint Michaels Medical Center
state: New Jersey
city: Bay Shore
country: United States
facility: South Shore University Hospital Northwell Health
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian-Weill Cornell Medical Center
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Cardiovascular Practice PC
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Cardiology
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Institute Presbyterian Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Moses H Cone Memorial Hospital
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Zanesville
country: United States
facility: Genesis Healthcare System
state: Ohio
city: Tulsa
country: United States
facility: Ascension Saint John Bartlesville
state: Oklahoma
city: Tulsa
country: United States
facility: Ascension Saint John Tulsa
state: Oklahoma
city: Chambersburg
country: United States
facility: Wellspan Chambersburg Hospital
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital/The Heart Group of Lancaster
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital Tower Health
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Warwick
country: United States
facility: Kent Hospital
state: Rhode Island
city: Columbia
country: United States
facility: Prisma Upstate and Midlands Greenville Hospital System
state: South Carolina
city: Greenville
country: United States
facility: Upstate Cardiology
state: South Carolina
city: Knoxville
country: United States
facility: Tennova Healthcare-Turkey Creek Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Ascension Saint Thomas Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Oak Ridge
country: United States
facility: Parkway Cardiology Associates
state: Tennessee
city: Powell
country: United States
facility: Cardiovascular Research of Knoxville North Knoxville Medical Center
state: Tennessee
city: Austin
country: United States
facility: Ascension Texas Cardiovascular
state: Texas
city: Kyle
country: United States
facility: Ascension Texas Cardiovascular Kyle
state: Texas
city: Midlothian
country: United States
facility: Bon Secours St Marys Hospital Richmond
state: Virginia
city: Richmond
country: United States
facility: Chippenham Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Saint Lukes Medical Center
state: Wisconsin
city: Rio Branco
country: Brazil
facility: Clínica Silvestre Sante
state: Acre
city: Linhares
country: Brazil
facility: Instituto Cardiovascular de Linhares
state: Espírito Santo
city: Ipiranga Goiânia
country: Brazil
facility: Hospital Ruy Azeredo
state: Goiás
city: Ipiranga Goiânia
country: Brazil
facility: Hospital Universitario Sao Francisco na Providencia de Deus
state: Goiás
city: Belo Horizonte
country: Brazil
facility: Hospital Madre Teresa
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Hospital Universitário Ciências Médicas de Belo Horizonte
state: Minas Gerais
city: Pocos de Caldas
country: Brazil
facility: Hospital do Coracao de Pocos de Caldas CEC servicos medicos
state: Minas Gerais
city: Casa Forte
country: Brazil
facility: Ps Cardiologico de PE - Procape
state: Pernambuco
city: Natal
country: Brazil
facility: Instituto Atena de Pesquisa Clínica
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa Clínica Associação Hospitalar Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Santa Casa de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Hospital Beneficência Portuguesa
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Cmep-Centro Multidisciplinar Ensino e Pesq
state: Santa Catarina
city: Praia Comprida, Sao Jose
country: Brazil
facility: Instituto de Cardiologia de Santa Catarina
state: Santa Catarina
city: Aracaju
country: Brazil
facility: Centro de Pesquisa Clinica do Coracao
state: Sergipe
city: Campinas
country: Brazil
facility: Instituto de Pesquisa Clínica de Campinas
state: São Paulo
city: Marilia
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Marilia
state: São Paulo
city: Presidente Prudente
country: Brazil
facility: Hospital Regional de Presidente Prudente
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazanesse
state: São Paulo
city: São Paulo
country: Brazil
facility: Instituto do coracao da Faculdade de Medicina da Universidade de Sao Paulo - InCor
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Alingsas
country: Sweden
facility: Alingsas Lasarett
city: Gavle
country: Sweden
facility: Gavle Sjukhus
city: Jonkoping
country: Sweden
facility: Lanssjukhuset Ryhov
city: Karlskrona
country: Sweden
facility: Blekingesjukhuset Karlskrona
city: Linkoping
country: Sweden
facility: Linkoping University Hospital
city: Lulea
country: Sweden
facility: Sunderby Sjukhus
city: Lund
country: Sweden
facility: Skane Universitetssjukhus i Lund
city: Molndahl
country: Sweden
facility: Molndals Sjukhus
city: Norrkoeping
country: Sweden
facility: Vrinnevisjukhuset, Norrkoeping
city: Ostersund
country: Sweden
facility: Ostersunds sjukhus
city: Stockholm
country: Sweden
facility: Sodersjukhuset
city: Sundsvall
country: Sweden
facility: Sundsvalls Sjukhus
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset i Uppsala
city: Vasteras
country: Sweden
facility: Vastmanlands Sjukhus Vasteras
city: Vaxjo
country: Sweden
facility: Centrallasarettet Vaxjo
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: