Fexofenadine to improve recovery after a heart attack
The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction: A Randomized Clinical Trial (FEND Ⅱ)
This trial will test whether taking the antihistamine fexofenadine after a recent STEMI heart attack helps reduce heart damage and improve recovery in adults.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2804 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07381803 on ClinicalTrials.gov |
What this trial studies
This is a phase 3, randomized, placebo-controlled trial comparing oral fexofenadine 60 mg to placebo in adults who had an ST-segment elevation myocardial infarction within the prior 7 days. Eligible participants must have typical STEMI findings including elevated troponin, new ST elevation on ECG, and segmental wall motion abnormalities on echocardiography. The study will use clinical follow-up and cardiac imaging (including cardiac MRI for fibrosis assessment) to measure prognosis and structural changes in the heart. The trial is conducted at the Second Affiliated Hospital, School of Medicine, Zhejiang University, with participants followed over defined post-MI timepoints for imaging and outcome assessment.
Who should consider this trial
Good fit: Adults aged 18 or older who had an acute STEMI within 7 days, with elevated troponin, new ST-segment elevation, and echocardiographic wall motion abnormalities who can give informed consent are ideal candidates.
Not a fit: Patients who require long-term fexofenadine or other contraindicated medications, those with non‑STEMI or who present more than 7 days after the event, or those with contraindications to the drug are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, fexofenadine could reduce post‑MI cardiac scarring and improve short- and long-term heart function and outcomes.
How similar studies have performed: This repurposing approach is relatively novel in humans: some preclinical and small observational studies suggest histamine pathways may affect fibrosis, but large randomized trials of antihistamines to prevent post‑MI fibrosis are lacking.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital of Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Cheng Ni
- Email: cescni@zju.edu.cn
- Phone: +8615088555539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.