NCT06548204 Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial
| NCT ID | NCT06548204 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | ST-segment Elevation Myocardial Infarction (STEMI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 152 participants in total. It began in 2025-01-20 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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; * 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.
Contact & Investigator
Xinyang Hu, PhD
PRINCIPAL INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Frequently Asked Questions
Who can join the NCT06548204 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ST-segment Elevation Myocardial Infarction (STEMI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06548204 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06548204 currently recruiting?
Yes, NCT06548204 is actively recruiting participants. Contact the research team at lsyrmxyc@126.com for enrollment information.
Where is the NCT06548204 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06548204 clinical trial?
NCT06548204 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The principal investigator is Xinyang Hu, PhD at 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China. The trial plans to enroll 152 participants.