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 \[STEMI\]).
Brief Title
EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Cardiovascular Disease
Myocardial Infarction
Stroke
Coronary Revascularization
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)
* 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)
Inclusion Criteria
Inclusion Criteria:
* Age greater than or equal to 18 years
* Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease
* Age greater than or equal to 18 years
* Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease
Gender
All
Gender Based
false
Keywords
Acute Myocardial Infarction
Cardiovascular Disease
Stroke
Coronary revascularization
Evolocumab
STEMI
NSTEMI
Heart Attack
Pragmatic
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
18 Years
NCT Id
NCT05284747
Org Class
Industry
Org Full Name
Amgen
Org Study Id
20190184
Overall Status
Active, not recruiting
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
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
Primary Outcomes
Outcome Measure
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death
Outcome Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Secondary Ids
Secondary Id
2021-005272-19
Secondary Outcomes
Outcome Description
Percent LDL-C change from baseline to 12 weeks in a subset of approximately 300 randomly selected participants.
Outcome Time Frame
From Baseline to Week 12
Outcome Measure
Percentage Change From Baseline in LDL-C
Outcome Description
Percent LDL-C change from baseline to 52 weeks in a subset of approximately 300 randomly selected participants.
Outcome Time Frame
From Baseline to Week 52
Outcome Measure
Percentage Change From Baseline in LDL-C
Outcome Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Outcome Measure
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death
Outcome Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Outcome Measure
Time to the First Occurrence of the Composite of Myocardial Infarction, Ischemic Stroke, any Arterial Revascularization Procedure, and All-Cause Death
Outcome Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Outcome Measure
Total Myocardial Infarctions Events
Outcome Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Outcome Measure
Total Arterial Revascularization Procedures
Outcome Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Outcome Measure
Total Ischemia-driven Coronary Revascularization Procedures
Outcome Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Outcome Measure
Total Ischemic Strokes
Outcome Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Outcome Measure
Time to Cardiovascular Death
Outcome Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Outcome Measure
Time to All-Cause Death
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Anna Bortnick
Investigator Email
abortnic@montefiore.org
Investigator Phone
718 904 3457