Fexofenadine to improve recovery after a heart attack

Is this trial a fit for you?

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.