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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects and safety of a medication called fexofenadine hydrochloride in patients who have experienced a heart attack known as ST-segment Elevation Myocardial Infarction (STEMI). The goal is to see if fexofenadine can help these patients after they receive standard treatment, which includes a procedure called percutaneous coronary intervention (PCI) to open blocked arteries. The trial is currently not recruiting participants, but when it begins, it will include adults over the age of 18 who can understand the study and give their consent to participate.

To be eligible for the trial, participants must have had a STEMI heart attack, characterized by specific symptoms like prolonged chest pain and certain changes in blood tests and heart monitoring. They should also have undergone emergency treatment within 12 hours of their symptoms. However, individuals with a history of severe kidney or liver issues, long-term use of similar medications, or certain other health conditions will not be able to participate. Those who join the study can expect to receive either the fexofenadine medication or a placebo (a treatment with no active medication) while being closely monitored for safety and effectiveness. This trial is important as it may help determine if fexofenadine can offer additional benefits to heart attack patients recovering from a serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Ages above 18;
• • Being able to verbally confirm understanding of the trial risks, benefits, and treatment options of receiving treatment with fexofenadine hydrochloride. He/she or his/her legal representative shall provide written informed consent before participating in the clinical trial.
• * Meet the diagnostic criteria for STEMI, the diagnostic criteria includes:
• • 1. Clinical symptoms: ischemic chest pain lasting for over 30 minites;
• • 2. Elevated serum cTn: at least once higher than the upper limit of normal values (99th percentile of the reference upper limit);
• • 3. ST segment elevation: new ST segment elevation in two or more adjacent leads on the ECG;
• • Emergency coronary angiography and revascularization should be performed within 12 hours of symptom onset;
• • Ultrasonic cardiogram indicates regional wall motion abnormality, and transthoracic echocardiography shows LVEF ≤ 50% within 72 hours after revascularization.
• Exclusion Criteria:
• • Long term use of fexofenadine hydrochloride or other H1 receptor inhibitors;
• • Previously suffered from myocardial infarction or received coronary artery bypass grafting;
• • History of severe renal failure, estimated glomerular filtration rate (eGFR) \< 30ml/min;
• • History of severe liver dysfunction, total bilirubin (TBil) \> the upper limit of normal, or AST/ALT \> 3 times the upper limit of normal, or alkaline phosphatase \> 2.5 times the upper limit of normal;
• • Concurrent severe infections, or liver/gallbladder obstruction, or history of malignant tumors;
• • Currently receiving immunosuppressive therapy;
• • Pregnant or potentially pregnant and breastfeeding women;
• • Contraindications for fexofenadine hydrochloride or cardiac magnetic resonance examinations;
• • Without obtaining written informed consent.