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Interleukin-1 Blocker

Anakinra for Heart Attack Prevention of Heart Failure (VA-ART4 Trial)

Phase 2
Recruiting
Led By Antonio Abbate, MD, PhD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Reperfusion strategy planned or completed (including percutaneous coronary intervention or fibrinolysis)
Age >21 years
Must not have
Failed reperfusion strategy (unsuccessful percutaneous coronary intervention)
Contraindications to treatment with anakinra (i.e. prior allergic reaction to Kineret® or E. coli derived products)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks

Summary

This trial will test if an anti-inflammatory can help reduce the risk of heart failure for people who have had a heart attack.

Who is the study for?
This trial is for adults over 21 who've had a recent heart attack and are receiving treatment to restore blood flow. They must not be pregnant, have severe psychiatric issues, limited English proficiency that affects understanding of the study, prior significant heart attacks or heart failure, allergies to anakinra or E. coli products, certain infections like COVID-19 or chronic diseases like hepatitis B/C and HIV/AIDS.
What is being tested?
The study is testing if Anakinra (an anti-inflammatory medicine) can reduce inflammation after a heart attack to prevent future heart weakening. Participants will either receive Anakinra or a placebo without knowing which one they're getting.
What are the potential side effects?
Anakinra may cause reactions at the injection site, increased risk of infections due to immune system suppression, headaches, nausea and possibly allergic reactions in those sensitive to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have undergone or am planned to undergo a procedure to restore blood flow to my heart.
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I am older than 21 years.
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I had severe chest pain indicating a heart attack within the last 12 hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart procedure to improve blood flow didn't work.
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I am not allergic to Kineret® or products made from E. coli.
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I have had a severe heart attack or my heart pumps poorly.
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I need or am planning to have urgent heart surgery.
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I have advanced kidney disease or am on dialysis.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Peak oxygen consumption (peak VO2)

Side effects data

From 2018 Phase 2 & 3 trial • 104 Patients • NCT01809132
19%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
Encephalopathy
6%
C. difficile infection
4%
Respiratory Failure
4%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
2%
Viremia
2%
Baceteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra & Pentoxifylline & Zinc Sulfate
Methylprednisolone
Observational

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: anakinraExperimental Treatment1 Intervention
Group II: placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
2016
Completed Phase 4
~1320

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
719 Previous Clinical Trials
22,895,752 Total Patients Enrolled
25 Trials studying Heart Failure
4,718 Patients Enrolled for Heart Failure
National Institute on Aging (NIA)NIH
1,802 Previous Clinical Trials
28,193,897 Total Patients Enrolled
43 Trials studying Heart Failure
213,396 Patients Enrolled for Heart Failure
University of VirginiaOTHER
785 Previous Clinical Trials
1,316,362 Total Patients Enrolled
12 Trials studying Heart Failure
1,491 Patients Enrolled for Heart Failure
Antonio Abbate, MD, PhDPrincipal InvestigatorVirginia Commonwealth University
13 Previous Clinical Trials
426 Total Patients Enrolled
6 Trials studying Heart Failure
256 Patients Enrolled for Heart Failure
Benjamin Van Tassell, PharmDPrincipal InvestigatorVirginia Commonwealth University
4 Previous Clinical Trials
176 Total Patients Enrolled
2 Trials studying Heart Failure
133 Patients Enrolled for Heart Failure

Media Library

Anakinra (Interleukin-1 Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05177822 — Phase 2
Heart Failure Research Study Groups: anakinra, placebo
Heart Failure Clinical Trial 2023: Anakinra Highlights & Side Effects. Trial Name: NCT05177822 — Phase 2
Anakinra (Interleukin-1 Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05177822 — Phase 2
~37 spots leftby Feb 2027
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