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RECRUITINGPhase 2INTERVENTIONAL

Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure

Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure: The Virginia - Anakinra Remodeling Trial 4

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Anakinra

Anakinra 100 mg/0.67 mL daily subcutaneous injection for up to 14 days, including up to 9 days outpatient treatment;

OTHER

Placebo

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

Locations (2)

University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States