Clinical Trials Study
Phase 4
EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction
Conditions: Cardiovascular Disease, Myocardial Infarction, Stroke, Coronary Revascularization
- Study #:
- NCT05284747
- Last Updated:
- 10/06/2025
- Recruitment Status:
- Active, not recruiting
- Estimated Study Completion Date:
- 05/29/2027
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 \[STEMI\]).
Age: 18 Years to 99 Years old
Gender: All
Start Date: 10/26/2022
Primary Completion Date (Estimated): 05/29/2027
Study Completion Date (Estimated): 05/29/2027
Accepts Healthy Volunteers: No
Trial Purpose and Description
Eligibility Criteria
Age: 18 Years to 99 Years old
Gender: All
Accepts 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)
Principal Investigator
Anna Bortnick, MD, PhD