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Monoclonal Antibodies

Cholesterol-Lowering Medication for Heart Attack (EVOLVE-MI Trial)

Phase 4
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater than or equal to 18 years
Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease
Must not have
Participants requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trialstudies if a cholesterol-lowering medication can reduce heart attack, stroke and death in people hospitalized for a heart attack.

Who is the study for?
This trial is for adults over 18 who are hospitalized due to a heart attack (NSTEMI or STEMI) presumed to be caused by plaque buildup in the arteries. It's not open to those needing intensive support like pumps or drugs for blood pressure at screening, or if their heart damage isn't due to artery issues.
What is being tested?
The EVOLVE-MI study tests whether giving Evolocumab with standard cholesterol management right after a heart attack is better than just routine care alone. The goal is to see if this can reduce further heart attacks, strokes, surgeries on arteries, and deaths.
What are the potential side effects?
Evolocumab may cause reactions where it's injected, flu-like symptoms, back pain, high blood pressure episodes, and allergic reactions. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I was hospitalized for a heart attack caused by blocked arteries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need machines or drugs to help my heart and blood pressure work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Percentage Change From Baseline in LDL-C

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Evolocumab + Routine Lipid ManagementExperimental Treatment2 Interventions
Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
Group II: Routine Lipid ManagementActive Control1 Intervention
Participants will receive routine lipid management per standard of care (SoC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evolocumab
2011
Completed Phase 4
~13010

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,433 Previous Clinical Trials
1,389,142 Total Patients Enrolled
Colorado Prevention CenterOTHER
12 Previous Clinical Trials
16,634 Total Patients Enrolled
MDStudy DirectorAmgen
971 Previous Clinical Trials
933,314 Total Patients Enrolled

Media Library

Evolocumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05284747 — Phase 4
Heart Attack Research Study Groups: Evolocumab + Routine Lipid Management, Routine Lipid Management
Heart Attack Clinical Trial 2023: Evolocumab Highlights & Side Effects. Trial Name: NCT05284747 — Phase 4
Evolocumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05284747 — Phase 4
Heart Attack Patient Testimony for trial: Trial Name: NCT05284747 — Phase 4
~3273 spots leftby May 2027
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