The trial is taking place at:
A

Ascension | Ascension Texas Cardiovascular

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EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

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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

6,000 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)

6,000 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

Trial contacts and locations

120

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Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

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