NCT05284747

EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6,019 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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 \[STEMI\]).

Conditions

• Cardiovascular Disease
• Myocardial Infarction
• Stroke
• Coronary Revascularization

Interventions

Type	Name	Description
DRUG	Evolocumab	Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection.
DRUG	Routine Lipid Management	Routine lipid management therapies will be administered at the discretion of the investigator per SoC.

Timeline

• Start date: 2022-10-26
• Primary completion: 2027-05-29
• Completion: 2027-05-29
• First posted: 2022-03-17
• Last updated: 2025-10-06

Locations

120 sites across 3 countries: United States, Brazil, Sweden

Regulatory

• FDA-regulated drug study