The Impact of Fexofenadine Hydrochloride on the Prognosis... | NCT07381803

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

NCT07381803

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Recruiting

Last Update Posted

Feb 2, 2026Actual

Enrollment

2,804Estimated

Phase

Phase 3

Conditions

Zhejiang University

Interventions

Fexofenadine 60 Mg Oral Tablet
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 27, 2025Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Jan 5, 2026

First Submission Date that Met QC Criteria

Jan 27, 2026

First Posted Date

Feb 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2026

Last Update Posted Date

Feb 2, 2026Actual

Label	Type	Description	Intervention Names
placebo	Placebo Comparator		Drug: Placebo
Fexofenadine	Experimental	60mg, BID	Drug: Fexofenadine 60 Mg Oral Tablet

Name	Type	Description	Arm Group Labels	Other Names
Fexofenadine 60 Mg Oral Tablet	Drug	Fexofenadine, 60mg BID oral	Fexofenadine

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
C093230	fexofenadine
D013607	Tablets

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations