Interleukin-1 blockade with RPH-104 in patients with acute ST-elevation myocardial infarction: study design and rationale

Abstract Background Myocardial injury of ST-segment elevation myocardial infarction (STEMI) initiates an intense inflammatory response that contributes to further damage and is a predictor increased risk death or heart failure (HF). Interleukin-1 (IL-1) key mediator local systemic damage. We postulate the use drug RPH-104, which selectively binds inactivates both α β isoforms IL-1 will lead decrease in severity be reflected by concentration hsCRP, as well rate fatal outcomes, frequency new cases HF, changes levels brain natriuretic peptide (BNP) structural functional echocardiographic parameters. Methods This double blind, randomized, placebo-controlled study 102 patients with STEMI receive single administration RPH-104 80 mg, 160 mg placebo (1:1:1). The primary endpoint hsCRP area under curve (AUC) from day 1 until 14. Secondary endpoints include AUC 28, hospitalizations due HF other cardiac non-cardiac reasons during 12-month follow-up period, (BNP, NT-pro-BNP), parameters period compared baseline. started October 2020 anticipated end 2Q 2022. Trial registration : ClinicalTrials.gov, NCT04463251. Registered on July 9,