EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

Phase 4

Active, not recruiting

• Conditions: Coronary Revascularization; Cardiovascular Disease; Myocardial Infarction; Stroke
• Interventions: Drug: Routine Lipid Management; Drug: Evolocumab

• Registration Number: NCT05284747
• Lead Sponsor: Amgen

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 \[STEMI\]).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-17
• Study Start: 2022-10-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2027-05-29
• Study Completion: 2027-05-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6019

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine Lipid Management	Routine Lipid Management	Participants will receive routine lipid management per standard of care (SoC).
Evolocumab + Routine Lipid Management	Routine Lipid Management	Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
Evolocumab + Routine Lipid Management	Evolocumab	Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	Percent LDL-C change from baseline to 52 weeks in a subset of approximately 300 randomly selected participants.
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)

Trial Locations

Locations (119)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Eastern Shore Research Institute; 🇺🇸 Fairhope, Alabama, United States

Heart Center Research LLC; 🇺🇸 Huntsville, Alabama, United States

Northern Arizona Healthcare Corporation Cardiovascular Institute; 🇺🇸 Flagstaff, Arizona, United States

Scottsdale Healthcare at Shea - HonorHealth; 🇺🇸 Scottsdale, Arizona, United States

Pima Heart and Vascular Clinical Research; 🇺🇸 Tucson, Arizona, United States

John Muir Health and Cardiovascular Institute; 🇺🇸 Concord, California, United States

VA Greater Los Angeles Healthcare System; 🇺🇸 Los Angeles, California, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California-Irvine; 🇺🇸 Orange, California, United States

Scroll for more (109 remaining)