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Active, Not Recruiting

NCT Number: NCT05284747

EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

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]).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Revascularization Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Stroke Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clínica Silvestre Sante, Rio Branco, Acre, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Evolocumab

Drug

Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection.

Other names: Repatha, AMG 145

Routine Lipid Management

Drug

Routine lipid management therapies will be administered at the discretion of the investigator per SoC.

Primary outcomes

  1. Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death

    Time frame: From Baseline to End of Study (Approximately 3.5 Years)

Secondary outcomes

  1. Percentage Change From Baseline in LDL-C

    Time frame: From Baseline to Week 12

    Percent LDL-C change from baseline to 12 weeks in a subset of approximately 300 randomly selected participants.

  2. Percentage Change From Baseline in LDL-C

    Time frame: From Baseline to Week 52

    Percent LDL-C change from baseline to 52 weeks in a subset of approximately 300 randomly selected participants.

  3. Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death

    Time frame: From Baseline to End of Study (Approximately 3.5 Years)

  4. Time to the First Occurrence of the Composite of Myocardial Infarction, Ischemic Stroke, any Arterial Revascularization Procedure, and All-Cause Death

    Time frame: From Baseline to End of Study (Approximately 3.5 Years)

  5. Total Myocardial Infarctions Events

    Time frame: From Baseline to End of Study (Approximately 3.5 Years)

  6. Total Arterial Revascularization Procedures

    Time frame: From Baseline to End of Study (Approximately 3.5 Years)

  7. Total Ischemia-driven Coronary Revascularization Procedures

    Time frame: From Baseline to End of Study (Approximately 3.5 Years)

  8. Total Ischemic Strokes

    Time frame: From Baseline to End of Study (Approximately 3.5 Years)

  9. Time to Cardiovascular Death

    Time frame: From Baseline to End of Study (Approximately 3.5 Years)

  10. Time to All-Cause Death

    Time frame: From Baseline to End of Study (Approximately 3.5 Years)

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • Colorado Prevention Center

Registry information

Official study title

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

Acronym: EVOLVE-MI

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2022
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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