NCT07381803

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,804

participants targeted

Target at P75+ for phase_3

Timeline
13mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jan 2025Jun 2027

Study Start

First participant enrolled

January 27, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 2, 2026

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

January 5, 2026

Last Update Submit

January 27, 2026

Conditions

Zhejiang University

Keywords

myocardial infarctioncardiac fibrosiscardiac MRI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • All-cause death

    24 months, 60 months after myocardial infarction

  • Recurrent myocardial infarction

    24 and 60 months after myocardial infarction

  • Stroke

    24 and 60 months after myocardial infarction

  • Hospitalization for heart failure

    24 and 60 months after myocardial infarction

  • Repeat revascularization driven by angina pectoris

    24 and 60 months after myocardial infarction

  • +3 more secondary outcomes

Study Arms (2)

placebo

PLACEBO COMPARATOR
Drug: Placebo

Fexofenadine

EXPERIMENTAL

60mg, BID

Drug: Fexofenadine 60 Mg Oral Tablet

Interventions

Fexofenadine 60 Mg Oral TabletDRUG

Fexofenadine, 60mg BID oral

Fexofenadine
PlaceboDRUG

placebo

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Interventions

fexofenadineTablets

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Central Study Contacts

Cheng Ni

CONTACT

+8615088555539cescni@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

February 2, 2026

Study Start

January 27, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

February 2, 2026

Record last verified: 2025-01

Locations

CN(1)