Recruitment Complete
Sponsor ID
20190184

EVOLVE-MI: EVOLocumab Very Early after Myocardial InfarctionEVOLVE-MI

Sponsor ID
20190184
Clinicaltrials.gov ID
NCT05284747
EUCTIS ID
N/A
EudraCT ID
2021-005272-19

Study Details

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]).

Additional Study Details

Phase
Phase 4
Product
Evolocumab
Type
Interventional
Masking
None (Open Label)
Enrollment
6019
Additional Study Details

Protocol Summary

Primary Outcome Measures

Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death

Timeframe: From Baseline to End of Study (Approximately 3.5 Years)

Secondary Outcome Measures

Percentage Change From Baseline in LDL-C

Timeframe: From Baseline to Week 12

Percentage Change From Baseline in LDL-C

Timeframe: From Baseline to Week 52

Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death

Timeframe: 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

Timeframe: From Baseline to End of Study (Approximately 3.5 Years)

Total Myocardial Infarctions Events

Timeframe: From Baseline to End of Study (Approximately 3.5 Years)

Total Arterial Revascularization Procedures

Timeframe: From Baseline to End of Study (Approximately 3.5 Years)

Total Ischemia-driven Coronary Revascularization Procedures

Timeframe: From Baseline to End of Study (Approximately 3.5 Years)

Total Ischemic Strokes

Timeframe: From Baseline to End of Study (Approximately 3.5 Years)

Time to Cardiovascular Death

Timeframe: From Baseline to End of Study (Approximately 3.5 Years)

Time to All-Cause Death

Timeframe: From Baseline to End of Study (Approximately 3.5 Years)

Locations

Location
Status
Contact Us
Location
University of Colorado Hospital
Aurora, CO, United States, 80045
Status
Recruiting
Location
Ascension Saint Thomas Nashville
Nashville, TN, United States, 37205
Status
Recruiting
Location
Ascension Texas Cardiovascular Kyle
Kyle, TX, United States, 78640
Status
Recruiting
Location
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil, 05652-900
Status
Recruiting
Location
Hospital Universitario Sao Francisco na Providencia de Deus
Ipiranga Goiânia, Goiás, Brazil, 74453-200
Status
Recruiting
Location
Ascension Texas Cardiovascular
Austin, TX, United States, 78705
Status
Recruiting
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