StudyFinder
Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure
RECRUITING
21 years and over
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.DRUG: Anakinra, OTHER: Placebo
Heart Failure
Benjamin Van Tassell, PharmD - bvantassell@vcu.edu
Abbate, Antonio
PHASE2
HM20022826
NCT05177822
See this study on ClinicalTrials.gov