Status:
NOT_YET_RECRUITING
Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
ST-segment Elevation Myocardial Infarction (STEMI)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Background: Cardiac fibrosis caused by acute myocardial infarction is one of the major causes of death for cardiovascular disease patients in China. Previous research found that expression of FMO2 in ...
Eligibility Criteria
Inclusion
- 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 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
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT06548204
Start Date
September 1 2024
End Date
September 1 2026
Last Update
August 12 2024
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