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

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

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

Study Overview

• Status: Recruiting
• Conditions: Zhejiang University
• Intervention / Treatment: Drug: Placebo; Drug: Fexofenadine 60 Mg Oral Tablet

• Study Type: Interventional
• Enrollment (Estimated): 2804
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Cheng Ni; Phone Number: +8615088555539; Email: cescni@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University, School of Medicine
      • Contact: Xinyang Hu; Phone Number: +86 13856166372; Email: hxy0507@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo; placebo
Experimental: Fexofenadine; 60mg, BID	Drug: Fexofenadine 60 Mg Oral Tablet; Fexofenadine, 60mg BID oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular and cerebrovascular events (MACCE)	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	All-cause death between 2 groups	24 months, 60 months after myocardial infarction
Recurrent myocardial infarction	Recurrent myocardial infarction between 2 groups	24 and 60 months after myocardial infarction
Stroke	Stroke incidence between 2 groups	24 and 60 months after myocardial infarction
Hospitalization for heart failure	The incidence of Hospitalization for heart failure between 2 groups	24 and 60 months after myocardial infarction
Repeat revascularization driven by angina pectoris	Repeat revascularization driven by angina pectoris between 2 groups	24 and 60 months after myocardial infarction
Left ventricular ejection fraction (LVEF%)	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.	24 months after myocardial infarction
Left ventricular end-systolic diameter (LVIDs)	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.	24 months after myocardial infarction
Left ventricular end-diastolic diameter (LVIDd)	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.	24 months after myocardial infarction

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: myocardial infarction; cardiac MRI; cardiac fibrosis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Pharmaceutical Preparations; Dosage Forms; Tablets; fexofenadine
• Other Study ID Numbers: YAN2025-1734

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No