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Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial
RECRUITINGPhase 2Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine
Actively Recruiting
PhasePhase 2
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Started2025-01-20
Est. completion2026-12-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06548204
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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; * 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; * 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.
Conditions2
Heart DiseaseST-segment Elevation Myocardial Infarction (STEMI)
Interventions1
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Actively Recruiting
PhasePhase 2
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Started2025-01-20
Est. completion2026-12-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06548204