Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: ST-segment Elevation Myocardial Infarction (STEMI)
In brief
The purpose of this study was to evaluate the efficacy and safety of fexofenadine hydrochloride on the basis of standard treatment after PCI in STEMI patients.
Key facts
- Study ID
- NCT06548204
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 152
- Starts
- 2025-01-20
- Expected to finish
- 2027-12-30
- Last updated by the study team
- 2026-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- Clinical symptoms: ischemic chest pain lasting for over 30 minites;
- Elevated serum cTn: at least once higher than the upper limit of normal values (99th percentile of the reference upper limit);
- ST segment elevation: new ST segment elevation in two or more adjacent leads on the ECG;
- Emergency coronary angiography and revascularization should be performed;
- Ultrasonic cardiogram indicates regional wall motion abnormality, and transthoracic echocardiography shows LVEF ≤ 50% within 72 hours after revascularization.
You may not qualify if…
- Long term use of fexofenadine hydrochloride or other H1 receptor inhibitors;
- Previously suffered from myocardial infarction or received coronary artery bypass grafting;
- Patients with concomitant cardiomyopathy or valve disease;
- History of severe renal failure, estimated glomerular filtration rate (eGFR) < 30ml/min;
- History of severe liver dysfunction;
- 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.
- Patients with hemodynamic instability.
Where it is running
- The 2nd Affiliated Hopital of Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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