EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amgen
Study ID
NCT05284747
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Cardiovascular Disease
  • Coronary Revascularization
  • Myocardial Infarction
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection.
  • Routine Lipid Management — DRUG
    Routine lipid management therapies will be administered at the discretion of the investigator per SoC.

Study Details

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 \[STEMI\]).

Key Dates

Start date
Oct 26, 2022
Status verified
Oct 2025
Primary completion
May 29, 2027
Completion
May 29, 2027

Study Design

Enrollment
6,019 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Evolocumab + Routine Lipid Management
    Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
  • Active Comparator: Routine Lipid Management
    Participants will receive routine lipid management per standard of care (SoC).

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) ]

Locations (81)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Eastern Shore Research InstituteFairhopeAlabama36532-
Heart Center Research LLCHuntsvilleAlabama35801-4317-
Northern Arizona Healthcare Corporation Cardiovascular InstituteFlagstaffArizona86001-
Scottsdale Healthcare at Shea - HonorHealthScottsdaleArizona85258-
Pima Heart and Vascular Clinical ResearchTucsonArizona85719-
John Muir Health and Cardiovascular InstituteConcordCalifornia94520-
University of California Los AngelesLos AngelesCalifornia90095-
VA Greater Los Angeles Healthcare SystemLos AngelesCalifornia90073-
University of California-IrvineOrangeCalifornia92868-
University of Colorado HospitalAuroraColorado80045-
Bridgeport HospitalBridgeportConnecticut06610-
Hartford HospitalHartfordConnecticut06106-
Cardiology Associates of Fairfield County PCStamfordConnecticut06905-
Excel Medical Clinical TrialsBoca RatonFlorida33434-
Clearwater Cardiovascular ConsultantsClearwaterFlorida33756-
University of Florida at GainesvilleGainesvilleFlorida32610-
University of Florida and Shands HospitalJacksonvilleFlorida32209-
AdventHealth OrlandoOrlandoFlorida32803-
Cardiology Partners Clinical Research InstitutePalm Beach GardensFlorida33410-
Ascension Sacred HeartPensacolaFlorida32504-
Baptist Health CarePensacolaFlorida32501-
Clearwater Cardiovascular ConsultantsSafety HarborFlorida34695-
Tampa Cardiovascular Interventions and ResearchTampaFlorida33614-
Clinical Site Partners Orlando dba Flourish ResearchWinter ParkFlorida32789-
Saint Lukes Boise Medical CenterBoiseIdaho83712-
Great Lakes Clinical Trials - RavenswoodChicagoIllinois60640-
Jesse Brown Veterans Affairs Medical CenterChicagoIllinois60612-
Advocate Lutheran General HospitalPark RidgeIllinois60068-
Ascension Saint Vincent Heart CenterIndianapolisIndiana46290-
Reid Physician AssociatesRichmondIndiana47374-
University of Kansas HospitalKansas CityKansas66160-
Midwest Heart and Vascular SpecialistsOverland ParkKansas66211-
University of Louisville Health - Jewish HospitalLouisvilleKentucky40202-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford HospitalDetroitMichigan48202-
Healthy Heart CardiologyGrand RapidsMichigan49546-
Sparrow Clinical Research InstituteLansingMichigan48912-
McLaren Macomb Research ServicesMount ClemensMichigan48043-
McLaren Northern Michigan HospitalPetoskeyMichigan49770-
Advanced Cardiology AssociatesRochester HillsMichigan48307-
Essentia Health Saint Marys Medical CenterDuluthMinnesota55805-
Jackson HeartJacksonMississippi39216-
Cardiology Associates of North MississippiTupeloMississippi38801-
Saint Lukes Hospital of Kansas CityKansas CityMissouri64111-
North Kansas City HospitalNorth Kansas CityMissouri64116-
Advanced Heart Care LLCBridgewaterNew Jersey08807-
Hackensack University Medical CenterHackensackNew Jersey07601-
Saint Michaels Medical CenterNewarkNew Jersey07102-
South Shore University Hospital Northwell HealthBay ShoreNew York11706-
New York Presbyterian-Weill Cornell Medical CenterNew YorkNew York10065-
Hudson Valley Cardiovascular Practice PCPoughkeepsieNew York12601-
University of Rochester Medical CenterRochesterNew York14642-
Richmond University Medical CenterStaten IslandNew York10310-
Stony Brook MedicineStony BrookNew York11794-
Montefiore Medical CenterThe BronxNew York10580-
University of North Carolina CardiologyChapel HillNorth Carolina27599-
Novant Health Heart and Vascular Institute Presbyterian Medical CenterCharlotteNorth Carolina28204-
Moses H Cone Memorial HospitalGreensboroNorth Carolina27401-
Aultman HospitalCantonOhio44710-
The Ohio State University Wexner Medical CenterColumbusOhio43210-
Genesis Healthcare SystemZanesvilleOhio43701-
Ascension Saint John BartlesvilleTulsaOklahoma74104-
Ascension Saint John TulsaTulsaOklahoma74104-
Wellspan Chambersburg HospitalChambersburgPennsylvania17201-
Lancaster General Hospital/The Heart Group of LancasterLancasterPennsylvania17603-
Reading Hospital Tower HealthWest ReadingPennsylvania19611-
Rhode Island HospitalProvidenceRhode Island02903-
Kent HospitalWarwickRhode Island02886-
Prisma Upstate and Midlands Greenville Hospital SystemColumbiaSouth Carolina29203-
Upstate CardiologyGreenvilleSouth Carolina29607-
Tennova Healthcare-Turkey Creek Medical CenterKnoxvilleTennessee37934-
Ascension Saint Thomas NashvilleNashvilleTennessee37205-
Vanderbilt University Medical CenterNashvilleTennessee37232-8802-
Parkway Cardiology AssociatesOak RidgeTennessee37830-
Cardiovascular Research of Knoxville North Knoxville Medical CenterPowellTennessee37849-
Ascension Texas CardiovascularAustinTexas78705-
Ascension Texas Cardiovascular KyleKyleTexas78640-
Bon Secours St Marys Hospital RichmondMidlothianVirginia23114-
Chippenham HospitalRichmondVirginia23225-
Aurora Saint Lukes Medical CenterMilwaukeeWisconsin53215-

Find similar trials in Birmingham, AL

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Alabama at Birmingham· Birmingham, ALEastern Shore Research Institute· Fairhope, ALHeart Center Research LLC· Huntsville, ALNorthern Arizona Healthcare Corporation Cardiovascular Institute· Flagstaff, AZScottsdale Healthcare at Shea - HonorHealth· Scottsdale, AZPima Heart and Vascular Clinical Research· Tucson, AZ

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