Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

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.

More ST-segment Elevation Myocardial Infarction (STEMI) trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment160 (estimated)
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Academic / other
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedJanuary 20, 2025
Main results expectedDecember 30, 2026
Study endsDecember 30, 2027
Registry record updatedSeptember 16, 2026
Trial IDNCT06548204 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

  • 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.