Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-31 @ 1:41 PM
Study NCT ID:
NCT05369351
Status:
RECRUITING
Last Update Posted:
2025-05-28
First Post:
2022-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-11-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-25', 'studyFirstSubmitDate': '2022-05-06', 'studyFirstSubmitQcDate': '2022-05-10', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in absolute perihematomal edema volume measured by computed tomography (CT)', 'timeFrame': '7 and 14 days', 'description': 'Repeated CT images will be obtained at 24-48 hours after diagnosis and on days 7 and 14 with CT at 24-48 hours after diagnosis as the baseline for analysis.'}], 'secondaryOutcomes': [{'measure': 'Changes in absolute hematoma volume measured by CT after ICH', 'timeFrame': '7 and 14 days', 'description': 'Repeated CT images will be obtained at 24-48 hours after diagnosis and on days 7 and 14 with CT at 24-48 hours after diagnosis as the baseline for analysis.'}, {'measure': 'Changes in NIHSS scores', 'timeFrame': '7 and 14 days', 'description': 'The assessment will be based on the National Institutes of Health Stroke Scale (NIHSS) with a score range of 0 (asymptomatic) to 42 (death).'}, {'measure': 'The rate of functional independence at 90 days', 'timeFrame': '90 days', 'description': 'Number of participants with functional independence. Modified Rankin scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.\n\nFunctional Independence:\n\n0 - no symptoms at all\n\n1 - no significant disability despite symptoms; able to carry out all usual duties and activities 2- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance'}, {'measure': 'Proportion of adverse drug reactions', 'timeFrame': '14 days', 'description': 'Adverse events related to mirabegron will be recorded.'}, {'measure': 'All cause mortality', 'timeFrame': '90 days', 'description': 'Death induced by any cause'}, {'measure': 'Changes of immune cells in peripheral blood', 'timeFrame': '14 days', 'description': 'The counts of monocytes subsets and other immune cells in peripheral blood were compared.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracerebral Haemorrhage']}, 'descriptionModule': {'briefSummary': 'Intracerebral hemorrhage (ICH) accounts for 10-15% of all strokes without effective pharmacological treatment. Inflammation following ICH contributes to barrier disruption and peri-hematoma edema, leading to deterioration of neurological function. Preclinical evidence suggests that bone marrow hematopoietic stem and progenitor cells (HSPCs) are swiftly activated after ICH. Thereafter, these HSPCs produce an increased output of anti-inflammatory monocytes as an endogenous protective mechanism. Stimulation of β3 adrenergic receptor using selective agonists promotes the production of anti-inflammatory monocytes in bone marrow, and thereby reduces neuroinflammation, brain edema and neurological deficits. This study is to assess the safety and efficacy of a β3 adrenergic receptor agonist Mirabegron as a potential treatment option in ICH patients.', 'detailedDescription': 'This study is to evaluate the efficacy and safety of mirabegron in patients with intracerebral hemorrhage based on standard therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients aged above 18 years old.\n2. The volume of the hematoma is 5-30 ml (including the cerebral cortex; Putamen, thalamus, caudate nucleus and related deep tracts; Cerebellar hemorrhage), which determined by CT scan.\n3. The onset of cerebral hemorrhage symptoms or the time from last normal to detection is not more than 72 hours.\n4. Patients with Glasgow Coma Scale (GCS) score ≥6 and \\< 12.\n5. Before the onset of the disease, function was independent and mRS score\\<1.\n6. Able and willing to sign written informed consent and comply with the requirements of the research protocol.\n\nExclusion criteria:\n\n1. Multifocal cerebral hemorrhage, brain stem hemorrhage, or ventricular hemorrhage.\n2. Secondary cerebral hemorrhage caused by aneurysm, brain tumor, arteriovenous malformation, thrombocytopenia, coagulation disorder, traumatic brain injury, etc.\n3. Patients who require hematoma removal surgery or other emergency surgical interventions (such as decompressive craniectomy), or who are critically ill and close to death.\n4. Patients who interfere with drug use due to nausea or vomiting.\n5. Combined with the following conditions that preclude participation in the study due to other systemic diseases: Severe hepatic or renal impairment, atrial fibrillation or tachycardia, pulmonary infection, severe urinary tract infection, severe urinary tract obstruction, medically uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg), pregnant and lactating women, and a history of malignant tumors within 5 years.'}, 'identificationModule': {'nctId': 'NCT05369351', 'briefTitle': 'Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University General Hospital'}, 'officialTitle': 'Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage', 'orgStudyIdInfo': {'id': 'IRB2022-YX-073-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard treatment+mirabegron', 'description': 'In addition to standard treatment, the first dose of mirabegron 50mg/day will be given within 72 hours of symptom onset and continued until the 7th day after onset.', 'interventionNames': ['Drug: Standard treatment+mirabegron']}, {'type': 'OTHER', 'label': 'Standard treatment', 'description': 'Patients will receive usual care', 'interventionNames': ['Other: Standard treatment']}], 'interventions': [{'name': 'Standard treatment+mirabegron', 'type': 'DRUG', 'description': 'In addition to standard treatment, the first dose of mirabegron 50mg/day will be given within 72 hours of symptom onset and continued until the 7th day after onset.', 'armGroupLabels': ['Standard treatment+mirabegron']}, {'name': 'Standard treatment', 'type': 'OTHER', 'description': 'Standard treatment', 'armGroupLabels': ['Standard treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Handong Li', 'role': 'CONTACT', 'email': 'handongli90@foxmail.com', 'phone': '+8615022439149'}], 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Handong Li', 'role': 'CONTACT', 'email': 'handongli90@foxmail.com', 'phone': '+8615022439149'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology Department', 'investigatorFullName': 'Qiang Liu', 'investigatorAffiliation': 'Tianjin Medical University General Hospital'}}}}