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NCT Number: NCT07381803

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Xinyang Hu

CONTACT

[email protected]

+86 13856166372

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fexofenadine 60 Mg Oral Tablet

Drug

Fexofenadine, 60mg BID oral

Placebo

Drug

placebo

Primary outcomes

  1. Major adverse cardiovascular and cerebrovascular events (MACCE)

    Time frame: 24 months

    MACCE within 24 months after randomization, including all-cause death, recurrent myocardial infarction, stroke, hospitalization for heart failure, outpatient or emergency visits due to worsening heart failure, and repeat revascularization driven by angina pectoris.

Secondary outcomes

  1. All-cause death

    Time frame: 24 months, 60 months after myocardial infarction

    All-cause death between 2 groups

  2. Recurrent myocardial infarction

    Time frame: 24 and 60 months after myocardial infarction

    Recurrent myocardial infarction between 2 groups

  3. Stroke

    Time frame: 24 and 60 months after myocardial infarction

    Stroke incidence between 2 groups

  4. Hospitalization for heart failure

    Time frame: 24 and 60 months after myocardial infarction

    The incidence of Hospitalization for heart failure between 2 groups

  5. Repeat revascularization driven by angina pectoris

    Time frame: 24 and 60 months after myocardial infarction

    Repeat revascularization driven by angina pectoris between 2 groups

  6. Left ventricular ejection fraction (LVEF%)

    Time frame: 24 months after myocardial infarction

    Comparison of the difference in left ventricular ejection fraction (LVEF%) measured by echocardiography between the two groups at 24 months after randomization compared to baseline.

  7. Left ventricular end-systolic diameter (LVIDs)

    Time frame: 24 months after myocardial infarction

    Comparison of the difference in left ventricular end-systolic diameter (LVIDs) measured by echocardiography between the two groups at 24 months after randomization compared to baseline.

  8. Left ventricular end-diastolic diameter (LVIDd)

    Time frame: 24 months after myocardial infarction

    Comparison of the difference in left ventricular end-diastolic diameter (LVIDd) measured by echocardiography between the two groups at 24 months after randomization compared to baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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