EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

Study Overview
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Brief Summary
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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]).

Official Title
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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

Conditions
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Cardiovascular Disease, Myocardial Infarction, Stroke, Coronary Revascularization

Intervention / Treatment
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* Drug: Evolocumab
* Drug: Routine Lipid Management


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evolocumab + Routine Lipid Management<br>Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management. | Drug: Evolocumab<br>* Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection.<br>* Other names: AMG 145;Drug: Routine Lipid Management<br>* Routine lipid management therapies will be administered at the discretion of the investigator per SoC.<br>|
| Active Comparator: Routine Lipid Management<br>Participants will receive routine lipid management per standard of care (SoC). | Drug: Routine Lipid Management<br>* Routine lipid management therapies will be administered at the discretion of the investigator per SoC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death |  | From Baseline to End of Study (Approximately 3.5 Years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline in LDL-C | Percent LDL-C change from baseline to 12 weeks in a subset of approximately 300 randomly selected participants. | From Baseline to Week 12 | 
| Percentage Change From Baseline in LDL-C | Percent LDL-C change from baseline to 52 weeks in a subset of approximately 300 randomly selected participants. | From Baseline to Week 52 | 
| 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) | 
| Total Arterial Revascularization Procedures |  | 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) | 
| Total Ischemic Strokes |  | From Baseline to End of Study (Approximately 3.5 Years) | 
| Time to Cardiovascular Death |  | From Baseline to End of Study (Approximately 3.5 Years) | 
| Time to All-Cause Death |  | From Baseline to End of Study (Approximately 3.5 Years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myocardial Infarction, Cardiovascular Disease, Stroke, Coronary revascularization, Evolocumab, STEMI, NSTEMI, Heart Attack, Pragmatic