Fexofenadine vs placebo after STEMI to see if it helps heart healing
Official title: Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT06548204 · Data updated 2026-11-12
This study tests whether fexofenadine hydrochloride added to standard care after PCI can improve heart function in adults who recently had a STEMI.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | January 20, 2025 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2027 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT06548204 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with STEMI treated by PCI and reduced left ventricular function (LVEF ≤ 50%) within 72 hours of revascularization.
✕Probably not a fit
Patients who do not respond to the intervention or who have contraindications to fexofenadine may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter, double‑blind, randomized controlled trial in adults with STEMI who have undergone PCI. Participants receive either fexofenadine hydrochloride or placebo in addition to standard treatment, to assess safety and potential improvement in cardiac outcomes. The trial builds on preclinical data suggesting fexofenadine may reduce cardiac fibrosis and promote better heart function after myocardial injury. Outcomes focus on efficacy and safety signals during follow‑up in the acute post‑PCI period.
Why it matters
Potential benefit: If successful, patients may experience better heart function and less fibrosis after a STEMI.
How similar studies have gone: This approach is novel in humans; prior animal data suggested potential benefit but clinical efficacy has not yet been demonstrated.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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The 2nd Affiliated Hopital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Xinyang Hu, PhD — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
- Study coordinator: Yinchuan Xu, PhD
- Email: lsyrmxyc@126.com
- Phone: 86-13968126628
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Adenosine given before primary PCI to reduce no-reflow in STEMI patients.
See if giving intracoronary adenosine before primary PCI lowers the chance of slow flow/no-reflow in adults with STEMI.
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Using cardiac MRI and AI to predict outcomes after STEMI
This project will try to use routine cardiac MRI scans plus AI to see if imaging features can predict long-term outcomes in people who had a STEMI treated with primary PCI.
-
Using beta-blockers for heart attack patients in intensive care
This study is testing if the heart medication metoprolol can help heart attack patients in intensive care feel better and avoid worsening their condition.
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Using an aspiration catheter for treating heart attacks
This study tests whether using a special catheter can help remove blood clots from the heart arteries during a heart attack to improve blood flow and patient recovery.
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Using machine learning to improve early diagnosis of acute cardiovascular conditions
This study is testing a new tool that uses advanced computer technology to help doctors quickly and accurately diagnose serious heart problems in patients who come to the emergency room with chest pain or trouble breathing.
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Administering adrenaline in STEMI patients during PCI to prevent no reflow
This study tests if giving adrenaline during heart procedures can help STEMI patients avoid complications with blood flow without causing heart rhythm problems.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.