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
Overview
- Phase
- Phase 4
- Intervention
- Routine Lipid Management
- Conditions
- Cardiovascular Disease
- Sponsor
- Amgen
- Enrollment
- 6019
- Locations
- 119
- Primary Endpoint
- Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
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]).
Investigators
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)
Arms & Interventions
Evolocumab + Routine Lipid Management
Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
Intervention: Routine Lipid Management
Routine Lipid Management
Participants will receive routine lipid management per standard of care (SoC).
Intervention: Routine Lipid Management
Evolocumab + Routine Lipid Management
Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
Intervention: Evolocumab
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Total Arterial Revascularization Procedures(From Baseline to End of Study (Approximately 3.5 Years))
- Total Ischemic Strokes(From Baseline to End of Study (Approximately 3.5 Years))
- Percentage Change From Baseline in LDL-C(From Baseline to Week 52)
- Time to All-Cause Death(From Baseline to End of Study (Approximately 3.5 Years))
- Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death(From Baseline to End of Study (Approximately 3.5 Years))
- Time to the First Occurrence of the Composite of Myocardial Infarction, Ischemic Stroke, any Arterial Revascularization Procedure, and All-Cause Death(From Baseline to End of Study (Approximately 3.5 Years))
- Total Myocardial Infarctions Events(From Baseline to End of Study (Approximately 3.5 Years))
- Time to Cardiovascular Death(From Baseline to End of Study (Approximately 3.5 Years))
- Total Ischemia-driven Coronary Revascularization Procedures(From Baseline to End of Study (Approximately 3.5 Years))