EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction
Purpose
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]).
Conditions
- Cardiovascular Disease
- Myocardial Infarction
- Stroke
- Coronary Revascularization
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Genders
- 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)
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
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). |
|
Recruiting Locations
University of Kansas Hospital
Kansas City, Kansas 66160
Kansas City, Kansas 66160
More Details
- Status
- Recruiting
- Sponsor
- Amgen