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Monoclonal Antibodies

Evolocumab for Acute Coronary Syndrome (EVACS Trial)

Phase 2
Waitlist Available
Led By Thorsten M Leucker, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non ST segment elevation myocardial infarction
Be older than 18 years old
Must not have
Patients requiring invasive hemodynamic support
ST elevation myocardial infarction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 30 days, 6 months

Summary

This trial tests evolocumab, a medication that lowers bad cholesterol, on patients with a specific type of heart attack. The medication works by blocking a protein that increases bad cholesterol and inflammation. The goal is to see if it can improve heart health and reduce inflammation in these patients.

Who is the study for?
This trial is for patients with a heart condition called non-ST elevation myocardial infarction (NSTEMI) and high levels of a heart damage marker (Troponin I > 5.0 ng/dL). It's not for those needing cardiac surgery, on other clinical trials, women who may get pregnant without proper birth control, anyone allergic to latex or monoclonal antibodies, or have used PCSK9 antibodies before.
What is being tested?
The study tests if Evolocumab, an antibody that lowers 'bad' cholesterol (LDL-C), can help reduce inflammation and stabilize the heart after an acute coronary syndrome when added to standard treatments. Some participants will receive Evolocumab while others will be given a placebo.
What are the potential side effects?
Evolocumab might cause reactions at the injection site, cold-like symptoms, back pain, and nausea. Since it affects the immune system by targeting cholesterol management processes in the body, there could also be rare but serious allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a heart attack that did not show ST elevation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need machines to help my heart and circulation work.
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I have had a severe type of heart attack.
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I am scheduled for heart surgery.
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I have been treated with a PCSK9 antibody.
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I cannot take statin medications due to health reasons.
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I am a woman who can have children and have not used birth control for the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 days, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 days, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in LDL-Cholesterol
Inflammation
Secondary study objectives
Change in Canadian Angina Class
Change in New York Heart Association (NYHA) Class
Change in ejection fraction as assessed by echocardiography
+9 more

Side effects data

From 2020 Phase 4 trial • 259 Patients • NCT03096288
5%
gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPR - Evolocumab
NPR - Placebo
HPR - Evolocumab
HPR - Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EvolocumabExperimental Treatment1 Intervention
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evolocumab
2011
Completed Phase 4
~13090

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,613 Total Patients Enrolled
4 Trials studying Acute Coronary Syndrome
400 Patients Enrolled for Acute Coronary Syndrome
Washington University School of MedicineOTHER
2,000 Previous Clinical Trials
2,344,202 Total Patients Enrolled
3 Trials studying Acute Coronary Syndrome
1,250 Patients Enrolled for Acute Coronary Syndrome
AmgenIndustry Sponsor
1,466 Previous Clinical Trials
1,401,436 Total Patients Enrolled
3 Trials studying Acute Coronary Syndrome
2,408 Patients Enrolled for Acute Coronary Syndrome
Thorsten M Leucker, MD, PhDPrincipal InvestigatorJohns Hopkins University

Media Library

Evolocumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03515304 — Phase 2
Acute Coronary Syndrome Research Study Groups: Evolocumab, Placebo
Acute Coronary Syndrome Clinical Trial 2023: Evolocumab Highlights & Side Effects. Trial Name: NCT03515304 — Phase 2
Evolocumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03515304 — Phase 2
~8 spots leftby Dec 2025
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