A Phase 2 Randomized Trial Comparing Fexofenadine Hydrochloride to Placebo for Treating ST-Segment Elevation Myocardial Infarction Patients After PCI

What this Trial Is About

Researchers are studying the effects of fexofenadine hydrochloride in patients who have experienced an acute myocardial infarction, specifically ST-segment Elevation Myocardial Infarction STEMI. The study aims to evaluate the efficacy and safety of adding fexofenadine hydrochloride to standard treatment after primary percutaneous coronary intervention PCI in patients with reduced left ventricular ejection fraction LVEF 50%. This is a phase 2, randomized, double-blind, placebo-controlled clinical trial conducted at multiple centers. Participants will be randomly assigned to receive either fexofenadine hydrochloride 60 mg twice daily or a matched placebo, starting 3 days after primary PCI and continuing for 6 months alongside standard treatment. The study evaluates the impact of fexofenadine hydrochloride on heart function and cardiac fibrosis, with a focus on its potential to increase FMO2 expression and reduce collagen deposition, based on prior animal research. During the 6-month treatment period, participants will undergo assessments including cardiac magnetic resonance imaging to measure late gadolinium enhancement relative to left ventricular mass and other heart function parameters such as LVEF, ventricular volumes, extracellular volume, and stroke volume. Additional outcomes include biomarker levels, exercise capacity, symptom questionnaires, adverse drug reactions, and major adverse cardiac events. Safety monitoring and follow-up occur throughout the study period ending in December 2027.

Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial