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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 30 days, 6 months
Awards & highlights

EVACS Trial Summary

This trial tests whether or not adding a PCSK9 antibody to current medical therapies would be beneficial for patients with non-ST elevation myocardial infarction (NSTEMI) by reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.

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.Check my eligibility
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.See study design
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.

EVACS Trial Eligibility Criteria

Inclusion Criteria

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

EVACS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in LDL-Cholesterol
Inflammation
Secondary outcome measures
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%
chest pain
5%
gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
HPR - Evolocumab
HPR - Placebo
NPR - Evolocumab
NPR - Placebo

EVACS 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
~13010

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,274 Previous Clinical Trials
14,840,458 Total Patients Enrolled
4 Trials studying Acute Coronary Syndrome
400 Patients Enrolled for Acute Coronary Syndrome
Washington University School of MedicineOTHER
1,945 Previous Clinical Trials
2,303,765 Total Patients Enrolled
3 Trials studying Acute Coronary Syndrome
1,250 Patients Enrolled for Acute Coronary Syndrome
AmgenIndustry Sponsor
1,383 Previous Clinical Trials
1,379,861 Total Patients Enrolled
3 Trials studying Acute Coronary Syndrome
2,408 Patients Enrolled for Acute Coronary Syndrome

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
~3 spots leftby Oct 2024
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