This is the classic website, which will be retired eventually. Please visit the modernized instead.
Working… Menu
Trial record 1 of 1 for:    virginia-ART4
Previous Study | Return to List | Next Study

Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure (Virginia-ART4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05177822
Recruitment Status : Recruiting
First Posted : January 5, 2022
Last Update Posted : May 3, 2023
National Institute on Aging (NIA)
University of Virginia
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
Patients who have a heart attack are at high risk for future development of heart failure ('weakening of the heart'). The researchers believe that the reaction of the heart muscle to injury (inflammation) during a heart attack may be contributing to the risk of heart failure. The current study will test the ability of an anti-inflammatory medicine (anakinra) to block the inflammation in the body during and after a heart attack.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Anakinra Other: Placebo Phase 2

Detailed Description:

Anakinra (Kineret®) is a 'copy' of a naturally occurring protein made by the body to block inflammation. The US Food and Drug Administration (FDA) has approved anakinra 100 mg daily for the treatment of rheumatoid arthritis but anakinra is not currently approved for the treatment of heart disease. Anakinra is generally well-tolerated, but can cause pain or redness at the injection site and may affect risk of infections. The study team will work with participants to help avoid (or manage) any side effects throughout the study.

The study is designed to measure how well anakinra can protect participants from developing heart failure. Participation in this study will last approximately 1 year. During the first 2 weeks of the study, participants will receive an injection with anakinra or placebo (a liquid that looks like anakinra but contains no active medicine). While hospitalized, a nurse will do the injections for participants; upon discharge participants will be taught to give the remaining injections at home. Assignment to treatment with anakinra or placebo will be determined by randomization (like the "flip of a coin"). Approximately 84 people will participate in this study over the course of 4 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure: The Virginia - Anakinra Remodeling Trial 4
Actual Study Start Date : May 24, 2022
Estimated Primary Completion Date : February 2027
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Arm Intervention/treatment
Experimental: anakinra Drug: Anakinra
Anakinra 100 mg/0.67 mL daily subcutaneous injection for up to 14 days, including up to 9 days outpatient treatment;
Other Name: Kineret

Placebo Comparator: placebo Other: Placebo
0.9% NaCl/0.67 mL daily subcutaneous injection for up to 14 days, including up to 9 days outpatient treatment.

Primary Outcome Measures :
  1. Peak oxygen consumption (peak VO2) [ Time Frame: 6 weeks ]
    Peak VO2 (expressed as % of predicted) will be assess using cardiopulmonary exercise testing (CPET)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

All criteria need to be met.

  • Acute ST segment elevation myocardial infarction defined as:

    • chest pain, consistent with angina, within the prior 12 hours (for intermittent pain lasting more than 12 hours, the time from the when the pain became severe and constant);
    • ST segment elevation on ECG >1 mm in 2 or more anatomically contiguous leads;
    • Reperfusion strategy planned or completed (including percutaneous coronary intervention or fibrinolysis)
  • Age >21 years.

Exclusion Criteria:

Subjects will not be eligible if they meet any of the following exclusion criteria.

  • Pregnancy;
  • Inability to obtain consent from patient;
  • History of prior STEMI or of systolic heart failure (LVEF<40%);
  • Contraindications to treatment with anakinra (i.e. prior allergic reaction to Kineret® or E. coli derived products);
  • Duration of chest pain >12 hours at time of coronary artery catheterization (continuously - see exceptions in Inclusion Criteria) or coronary artery intervention >12 hours earlier (see exceptions in Inclusion Criteria)[max duration of chest pain 24 hours];
  • Failed reperfusion strategy (unsuccessful percutaneous coronary intervention);
  • Need or plan for emergent cardiac surgery;
  • Anticipated inability to complete a cardiopulmonary exercise test (CPET) on a treadmill at follow up visit at 42 days (i.e. amputee, wheel-chair bound, severe non-cardiac illness limiting mobility).
  • Active infection (such as acute, i.e. COVID-19, or chronic/recurrent infectious disease i.e HBV, HCV, and HIV/AIDS-but excluding HCV+ patients with undetectable plasma RNA)
  • Acute or chronic inflammatory disease or immunosuppressive therapies (including oral corticosteroids at a dose of prednisone equivalent of 0.5 mg/kg/day but not including inhaled or low dose oral corticosteroids or non-steroidal anti-inflammatory drugs).
  • Neutropenia (<1,500/mm3 or <1,000/mm3 in African-American patients).
  • Active acute or chronic psychiatric illness that in the opinion of the investigator may prevent from complying with study instructions;
  • Stage V chronic kidney disease (estimated glomerular filtration rate 15 mL/min/1.73m2 or less) or on renal-replacement therapy (a GFR ≥45 mL/min/1.73m2 is required for the cardiac magnetic resonance portion of the study);
  • Limited English Proficiency that in the opinion of the investigator may prevent from understanding the content of the informed consent form and instructions during the tests required for the study.
  • Any comorbidity limiting survival or ability to complete the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05177822

Layout table for location contacts
Contact: Benjamin Van Tassell, PharmD 804-828-4583

Layout table for location information
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Linda Bryceland, RN, CCRC    434-982-1058   
Principal Investigator: Antonio Abbate, MD         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Benjamin Van Tassell, PharmD    804-828-4583   
Principal Investigator: Benjamin Van Tassell, PharmD         
Sponsors and Collaborators
Virginia Commonwealth University
National Institute on Aging (NIA)
University of Virginia
Layout table for investigator information
Principal Investigator: Benjamin Van Tassell, PharmD Virginia Commonwealth University
Layout table for additonal information
Responsible Party: Virginia Commonwealth University Identifier: NCT05177822    
Other Study ID Numbers: HM20022826
R01AG076360 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2022    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A simplified and fully de-identified database will be made available for sharing in accordance with requirements for National Institute on Aging (NIA) data repository datasets and associated documentation for submission to the Biological Specimen and Data Repository Information Coordinating Center (BioLINCC) and the NIA Guidance on Sharing Data and other Resources, within 3 years of completion of the study.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents