EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

Amgen

Status and phase: Active, not recruiting; Phase 4

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

Treatments: Drug: Evolocumab; Drug: Routine Lipid Management

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05284747

2021-005272-19 (EudraCT Number)

20190184

Details and patient eligibility

About

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]).

Enrollment: 6,019 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,019 participants in 2 patient groups

Evolocumab + Routine Lipid Management

Experimental group

Description:

Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.

Treatment:

Drug: Routine Lipid Management

Drug: Evolocumab

Routine Lipid Management

Active Comparator group

Description:

Participants will receive routine lipid management per standard of care (SoC).

Treatment:

Drug: Routine Lipid Management