Clinical Trials Study

Phase 4

EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

Conditions: Cardiovascular Disease, Myocardial Infarction, Stroke, Coronary Revascularization

Study #:
NCT05284747
Last Updated:
10/06/2025
Recruitment Status:
Active, not recruiting
Estimated Study Completion Date:
05/29/2027

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 \[STEMI\]).

Age: 18 Years to 99 Years old

Gender: All

Start Date: 10/26/2022

Primary Completion Date (Estimated): 05/29/2027

Study Completion Date (Estimated): 05/29/2027

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 18 Years to 99 Years old

Gender: All

Accepts Healthy Volunteers: No

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)

Principal Investigator

Anna Bortnick, MD, PhD

For more information about this study, contact:

Anna Bortnick

718 904 3457

abortnic@montefiore.org