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Clinical Trials in Brazil / NCT05284747
Active, not recruiting Phase 4

EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

NCT05284747 · tracked via the Priya Life Science Brazil tracker
Sponsor
Amgen
Phase
Phase 4
Started
2022-10-26
Last updated
2025-10-06

Condition(s) studied

Cardiovascular DiseaseMyocardial InfarctionStrokeCoronary Revascularization

Investigational drug(s) / intervention(s)

Evolocumab →Routine Lipid Management

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (120)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Eastern Shore Research Institute Fairhope Alabama
Heart Center Research LLC Huntsville Alabama
Northern Arizona Healthcare Corporation Cardiovascular Institute Flagstaff Arizona
Scottsdale Healthcare at Shea - HonorHealth Scottsdale Arizona
Pima Heart and Vascular Clinical Research Tucson Arizona
John Muir Health and Cardiovascular Institute Concord California
VA Greater Los Angeles Healthcare System Los Angeles California
University of California Los Angeles Los Angeles California
University of California-Irvine Orange California
University of Colorado Hospital Aurora Colorado
Bridgeport Hospital Bridgeport Connecticut
Hartford Hospital Hartford Connecticut
Cardiology Associates of Fairfield County PC Stamford Connecticut
Excel Medical Clinical Trials Boca Raton Florida
Clearwater Cardiovascular Consultants Clearwater Florida
University of Florida at Gainesville Gainesville Florida
University of Florida and Shands Hospital Jacksonville Florida
AdventHealth Orlando Orlando Florida
Cardiology Partners Clinical Research Institute Palm Beach Gardens Florida
Baptist Health Care Pensacola Florida
Ascension Sacred Heart Pensacola Florida
Clearwater Cardiovascular Consultants Safety Harbor Florida
Tampa Cardiovascular Interventions and Research Tampa Florida
Clinical Site Partners Orlando dba Flourish Research Winter Park Florida
Saint Lukes Boise Medical Center Boise Idaho
Jesse Brown Veterans Affairs Medical Center Chicago Illinois
Great Lakes Clinical Trials - Ravenswood Chicago Illinois
Advocate Lutheran General Hospital Park Ridge Illinois
Ascension Saint Vincent Heart Center Indianapolis Indiana
Reid Physician Associates Richmond Indiana
University of Kansas Hospital Kansas City Kansas
Midwest Heart and Vascular Specialists Overland Park Kansas
University of Louisville Health - Jewish Hospital Louisville Kentucky
Massachusetts General Hospital Boston Massachusetts
Henry Ford Hospital Detroit Michigan
Healthy Heart Cardiology Grand Rapids Michigan
Sparrow Clinical Research Institute Lansing Michigan
McLaren Macomb Research Services Mount Clemens Michigan
McLaren Northern Michigan Hospital Petoskey Michigan

+ 80 more sites — see the full list on the official registry below.

On this site

📄 Repatha (evolocumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05284747 on ClinicalTrials.gov ↗ ← All trials in Brazil