← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 30 days, 6 months

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

chest pain

gastrointestinal bleeding

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,260 Previous Clinical Trials

14,820,720 Total Patients Enrolled

4 Trials studying Acute Coronary Syndrome

400 Patients Enrolled for Acute Coronary Syndrome

Washington University School of MedicineOTHER

1,933 Previous Clinical Trials

2,299,665 Total Patients Enrolled

3 Trials studying Acute Coronary Syndrome

1,250 Patients Enrolled for Acute Coronary Syndrome

AmgenIndustry Sponsor

1,370 Previous Clinical Trials

1,377,628 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment novel in its approach?

"Research on evolocumab began in 2018, with its first study being sponsored by Hoffmann-La Roche. After unanimously passing Phase 1 & 2 approval trials involving 435 participants, 22 current studies have been initiated across 35 nations and 240 cities."

Answered by AI

Are researchers currently seeking new participants for this investigation?

"This medical trial has stopped seeking participants, with its initial listing posted on May 20th 2018 and the latest update occurring on August 25th 2022. For those looking for active studies in this field, there are presently 1438 trials regarding acute coronary syndrome as well as 22 involving evolocumab that are actively searching for patients."

Answered by AI

What is the cap on total participants in this research project?

"The recruitment phase of this trial is now closed, with the initial posting being made on May 20th 2018 and the last edits to the study occuring August 25th 2022. For other studies involving acute coronary syndrome, 1438 trials are presently enrolling patients while 22 Evolocumab clinical trials are currently in need of participants."

Answered by AI

Does eligibility for this clinical trial extend to individuals younger than sixty years of age?

"For this research project, only individuals aged 25 years or older and younger than 90 are eligible for enrollment."

Answered by AI

To what degree could Evolocumab put patients at risk?

"Based on the available evidence, our team at Power assigned a 2 to Evolocumab's safety rating as this is a phase 2 trial with some data indicating its security but none affirming its efficacy."

Answered by AI

Who is eligible to partake in this research project?

"This trial seeks to accept sixty individuals with acute coronary syndrome that are between 25 and 90 years of age."

Answered by AI

What are the objectives of this experiment?

"This 30-day trial seeks to evaluate changes in LDL cholesterol with secondary objectives including alterations of interleukin 1 levels, high sensitivity C-reactive protein concentrations and left ventricular volume assessed via echocardiography."

Answered by AI

Recent research and studies

The American Journal of CardiologyJournal

The Trajectory of Lipoprotein(a) During the Peri- and Early Postinfarction Period and the Impact of Proprotein Convertase Subtilisin/kexin Type 9 Inhibition

Vavuranakis, Michael A., Steven R. Jones, Efthymios Ziogos, Michael J. Blaha, Marlene S. Williams, Palmer Foran, Thomas H. Schindler, et al.. 2022. “The Trajectory of Lipoprotein(a) During the Peri- and Early Postinfarction Period and the Impact of Proprotein Convertase Subtilisin/kexin Type 9 Inhibition”. The American Journal of Cardiology. Elsevier BV. doi:10.1016/j.amjcard.2022.01.058.

clinicaltrials.govStudy

Evolocumab in Acute Coronary Syndrome

2018. "Evolocumab in Acute Coronary Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03515304.