Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:05 AM
Study NCT ID:
NCT07381803
Status:
RECRUITING
Last Update Posted:
2026-02-02
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093230', 'term': 'fexofenadine'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-12-15', 'size': 254749, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-12-31T19:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2804}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiovascular and cerebrovascular events (MACCE)', 'timeFrame': '24 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': '24 months, 60 months after myocardial infarction', 'description': 'All-cause death between 2 groups'}, {'measure': 'Recurrent myocardial infarction', 'timeFrame': '24 and 60 months after myocardial infarction', 'description': 'Recurrent myocardial infarction between 2 groups'}, {'measure': 'Stroke', 'timeFrame': '24 and 60 months after myocardial infarction', 'description': 'Stroke incidence between 2 groups'}, {'measure': 'Hospitalization for heart failure', 'timeFrame': '24 and 60 months after myocardial infarction', 'description': 'The incidence of Hospitalization for heart failure between 2 groups'}, {'measure': 'Repeat revascularization driven by angina pectoris', 'timeFrame': '24 and 60 months after myocardial infarction', 'description': 'Repeat revascularization driven by angina pectoris between 2 groups'}, {'measure': 'Left ventricular ejection fraction (LVEF%)', 'timeFrame': '24 months after myocardial infarction', 'description': '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.'}, {'measure': 'Left ventricular end-systolic diameter (LVIDs)', 'timeFrame': '24 months after myocardial infarction', 'description': '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.'}, {'measure': 'Left ventricular end-diastolic diameter (LVIDd)', 'timeFrame': '24 months after myocardial infarction', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myocardial infarction', 'cardiac fibrosis', 'cardiac MRI'], 'conditions': ['Zhejiang University']}, 'descriptionModule': {'briefSummary': 'The goal of this study is o evaluate the prognostic effect of fexofenadine hydrochloride in patients with myocardial infarction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* 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.\n* Acute ST-segment elevation myocardial infarction (STEMI) occurring within 7 days, with diagnostic criteria including:\n\n 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.\n* Echocardiography indicating segmental wall motion abnormalities.\n\nExclusion Criteria:\n\n* Need for long-term use of fexofenadine hydrochloride or other H1 receptor inhibitors.\n* Previous coronary artery bypass grafting (CABG) surgery.\n* History of severe renal failure with estimated glomerular filtration rate (eGFR) \\< 30 ml/min.\n* History of severe liver dysfunction.\n* History of concurrent severe infection, hepatobiliary obstruction, or malignant tumor.\n* Expected life expectancy of less than 2 years due to non-cardiac diseases.\n* Currently receiving immunosuppressive therapy.\n* Pregnant, potentially pregnant, or lactating women.\n* Contraindication to the study drug or examinations.\n* Failure to provide written informed consent.\n* 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.'}, 'identificationModule': {'nctId': 'NCT07381803', 'briefTitle': 'The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction: A Randomized Clinical Trial (FEND Ⅱ)', 'orgStudyIdInfo': {'id': 'YAN2025-1734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Fexofenadine', 'description': '60mg, BID', 'interventionNames': ['Drug: Fexofenadine 60 Mg Oral Tablet']}], 'interventions': [{'name': 'Fexofenadine 60 Mg Oral Tablet', 'type': 'DRUG', 'description': 'Fexofenadine, 60mg BID oral', 'armGroupLabels': ['Fexofenadine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinyang Hu', 'role': 'CONTACT', 'email': 'hxy0507@zju.edu.cn', 'phone': '+86 13856166372'}], 'facility': 'The Second Affiliated Hospital of Zhejiang University, School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Cheng Ni', 'role': 'CONTACT', 'email': 'cescni@zju.edu.cn', 'phone': '+8615088555539'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}