NCT07381803 The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction
| NCT ID | NCT07381803 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Zhejiang University |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,804 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2026-12 |
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.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 2,804 participants in total. It began in 2025-01-27 with a primary completion date of 2026-12.
⚠ 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 goal of this study is o evaluate the prognostic effect of fexofenadine hydrochloride in patients with myocardial infarction
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old. * Able to verbally confirm understanding of the trial risks, benefits, and treatment options of fexofenadine hydrochloride therapy. He/she or his/her legal representative must provide written informed consent prior to participating in the clinical trial. * Acute ST-segment elevation myocardial infarction (STEMI) occurring within 7 days, with diagnostic criteria including: i) Typical clinical symptoms: such as severe crushing pain in the retrosternal or precordial area, usually lasting more than 10-20 minutes, which may radiate to the left upper arm, jaw, neck, back, or shoulders, etc.; ii) Elevated serum cardiac troponin (cTn): at least one measurement above the upper limit of normal (99th percentile of the reference upper limit); iii) ST-segment elevation: new ST-segment elevation at the J point in 2 adjacent leads. * Echocardiography indicating segmental wall motion abnormalities. Exclusion Criteria: * Need for long-term use of fexofenadine hydrochloride or other H1 receptor inhibitors. * Previous coronary artery bypass grafting (CABG) surgery. * History of severe renal failure with estimated glomerular filtration rate (eGFR) \< 30 ml/min. * History of severe liver dysfunction. * History of concurrent severe infection, hepatobiliary obstruction, or malignant tumor. * Expected life expectancy of less than 2 years due to non-cardiac diseases. * Currently receiving immunosuppressive therapy. * Pregnant, potentially pregnant, or lactating women. * Contraindication to the study drug or examinations. * Failure to provide written informed consent. * Presence of mechanical complications (ventricular septal defect, papillary muscle dysfunction, acute mitral regurgitation), refractory cardiogenic shock unresponsive to vasopressors, acute left heart failure or pulmonary edema, or malignant arrhythmias uncontrolled by antiarrhythmic drugs at enrollment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07381803 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Zhejiang University. 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 NCT07381803 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 2,804 participants.
Is NCT07381803 currently recruiting?
Yes, NCT07381803 is actively recruiting participants. Contact the research team at cescni@zju.edu.cn for enrollment information.
Where is the NCT07381803 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07381803 clinical trial?
NCT07381803 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 2,804 participants.