Vanderbilt Clinical Trials

EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

Purpose

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

Eligibility

Eligible Ages: Between 18 Years and 99 Years
Eligible Genders: 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)

Study Design

Phase: Phase 4
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Evolocumab + Routine Lipid Management	Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.	Drug: Evolocumab Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection. Other names: Repatha AMG 145 Drug: Routine Lipid Management Routine lipid management therapies will be administered at the discretion of the investigator per SoC.
Active Comparator Routine Lipid Management	Participants will receive routine lipid management per standard of care (SoC).	Drug: Evolocumab Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection. Other names: Repatha AMG 145 Drug: Routine Lipid Management Routine lipid management therapies will be administered at the discretion of the investigator per SoC.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232-8802

More Details

Status: Recruiting
Sponsor: Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.