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Interleukin-1 Blocker
Anakinra for Heart Attack Prevention of Heart Failure (Virginia-ART4 Trial)
Phase 2
Recruiting
Led By Benjamin Van Tassell, PharmD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Virginia-ART4 Trial 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.Check my eligibility
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.See study design
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.
Virginia-ART4 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have undergone or am planned to undergo a procedure to restore blood flow to my heart.
Select...
I am older than 21 years.
Select...
I had severe chest pain indicating a heart attack within the last 12 hours.
Virginia-ART4 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Peak oxygen consumption (peak VO2)
Side effects data
From 2018 Phase 2 & 3 trial • 104 Patients • NCT0180913219%
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
Virginia-ART4 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
~2260
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
699 Previous Clinical Trials
22,884,961 Total Patients Enrolled
23 Trials studying Heart Failure
4,691 Patients Enrolled for Heart Failure
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,801 Total Patients Enrolled
42 Trials studying Heart Failure
213,231 Patients Enrolled for Heart Failure
University of VirginiaOTHER
754 Previous Clinical Trials
1,244,989 Total Patients Enrolled
11 Trials studying Heart Failure
1,468 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My chest pain lasted more than 12 hours before my heart artery procedure.My heart procedure to improve blood flow didn't work.I am not allergic to Kineret® or products made from E. coli.Your neutrophil count is too low.I do not have an active infection like COVID-19, HBV, HCV (unless undetectable), or HIV/AIDS.Your ECG shows a specific type of heart abnormality called "ST segment elevation" in more than one area of your heart.I cannot do a treadmill exercise test due to severe mobility issues.You have another health problem that could make it hard for you to finish the study or live for a long time.I am not on high-dose steroids or immunosuppressive treatments.I have had a severe heart attack or my heart pumps poorly.I have undergone or am planned to undergo a procedure to restore blood flow to my heart.I am older than 21 years.I need or am planning to have urgent heart surgery.I have advanced kidney disease or am on dialysis.I had severe chest pain indicating a heart attack within the last 12 hours.
Research Study Groups:
This trial has the following groups:- Group 1: anakinra
- Group 2: placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment and enrollment still available for this research project?
"That is accurate. The clinical trial in question, which was first made public on May 24th, 2022, currently has an open call for 84 participants at 2 locations."
Answered by AI
What are Anakinra's side effects in people?
"While there is some evidence to support the safety of Anakinra, as this is only a Phase 2 trial, none of the data collected thus far supports its efficacy."
Answered by AI
What other drug tests have included Anakinra?
"At the moment, Anakinra is being trialled in 34 different ongoing clinical trials. Of these active studies, 6 are in Phase 3. Most of the research locations for this medication are situated in Paris and its surrounding area; however, there are 440 total trial sites for this drug."
Answered by AI
How many people fit the criteria to join this clinical trial?
"Yes, if you consult clinicaltrials.gov, you'll see that this trial is still looking for volunteers. The study was created on 5/24/2022 and updated most recently on 9/7/2022. They are recruiting for a total of 84 individuals at 2 sites."
Answered by AI
For what purposes is Anakinra typically prescribed?
"Anakinra is not only useful for treating systemic juvenile idiopathic arthritis (sjia), but can be employed in the treatment of other conditions such as neonatal-onset multisystem inflammatory disease (nomid) and various types of interleukin-1 receptors."
Answered by AI
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