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Recruiting NCT07381803

The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction

Phase III Interventional Zhejiang University

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fexofenadine 60 Mg Oral Tablet, Placebo.
Who it may be relevant to
Registry conditions: Zhejiang University. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction: A Randomized Clinical Trial (FEND Ⅱ)

Overview

The goal of this study is o evaluate the prognostic effect of fexofenadine hydrochloride in patients with myocardial infarction

Interventions

  • Drug Fexofenadine 60 Mg Oral Tablet
    Fexofenadine, 60mg BID oral
  • Drug Placebo
    placebo

Primary outcome measures

  • Major adverse cardiovascular and cerebrovascular events (MACCE) [Time frame: 24 months]
Secondary outcome measures (8)
  • All-cause death [Time frame: 24 months, 60 months after myocardial infarction]
  • Recurrent myocardial infarction [Time frame: 24 and 60 months after myocardial infarction]
  • Stroke [Time frame: 24 and 60 months after myocardial infarction]
  • Hospitalization for heart failure [Time frame: 24 and 60 months after myocardial infarction]
  • Repeat revascularization driven by angina pectoris [Time frame: 24 and 60 months after myocardial infarction]
  • Left ventricular ejection fraction (LVEF%) [Time frame: 24 months after myocardial infarction]
  • Left ventricular end-systolic diameter (LVIDs) [Time frame: 24 months after myocardial infarction]
  • Left ventricular end-diastolic diameter (LVIDd) [Time frame: 24 months after 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Zhejiang University, School of Medicine — Hangzhou

Identifiers

NCT: NCT07381803 · YAN2025-1734

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗