Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 4:44 PM
Study NCT ID:
NCT04857632
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2021-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Statin for Neuroprotection in Spontaneous 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-19', 'studyFirstSubmitDate': '2021-04-20', 'studyFirstSubmitQcDate': '2021-04-20', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perihemorrhagic edema to hematoma ratio', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Absolute perihematomal edema changes', 'timeFrame': '7 days'}, {'measure': 'Hematoma resolution rate', 'timeFrame': '7 days'}, {'measure': 'Absolute hematoma volume changes', 'timeFrame': '7 days'}, {'measure': 'Ordinal distribution of modified Rankin scale scores', 'timeFrame': '90 days', 'description': 'The modified Rankin scale is a 7-point scale ranging from 0 (no symptoms) to 6 (death).'}, {'measure': 'Proportion of patients with modified Rankin scale score 0-2', 'timeFrame': '90 days'}, {'measure': 'Proportion of patients with modified Rankin scale score 0-3', 'timeFrame': '90 days'}, {'measure': 'Rate of mortality', 'timeFrame': '30 dyas'}, {'measure': 'National Institute of Health stroke scale', 'timeFrame': '7 days or discharge', 'description': 'Scores on the National Institutes of Health Stroke Scale range from 0 to 42, with higher scores indicating more severe neurologic deficits.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracerebral Hemorrhage', 'Statins']}, 'referencesModule': {'references': [{'pmid': '38908848', 'type': 'DERIVED', 'citation': 'Gao D, Chu X, Zhang Y, Yan H, Niu L, Jiang X, Bao S, Ji X, Wu C. Statins for neuroprotection in spontaneous intracerebral haemorrhage (STATIC): protocol for a multicentre, prospective and randomised controlled trial. BMJ Open. 2024 Jun 21;14(6):e079879. doi: 10.1136/bmjopen-2023-079879.'}]}, 'descriptionModule': {'briefSummary': 'Brain injury after spontaneous intracerebral hemorrhage results from pathophysiologic responses in the brain parenchyma due to hematoma formation, release of clot components, and surrounding edema. Inflammatory cascade activation in the perihematomal brain parenchyma has been implicated in the pathogenesis of secondary brain injury. Statins have been identified as a potential neuroprotective agent that targets the inflammatory response to intracerebral hemorrhage. In preclinical studies, statin treatment in animal intracerebral hemorrhage models has consistently demonstrated neuroprotective and recovery enhancement effects. Clinical investigations in humans reported better patient outcomes associated with statin use in patients with intracerebral hemorrhage, including reduced perihematomal edema, lower mortality rates, and improved functional outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Age of 18 years or older', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age of 18 years or older\n* A clinical diagnosis of supratentorial intracerebral hemorrhage is confirmed by brain CT scan\n* Hematoma volume ≤40ml\n* The first dose of statin can be given within 24h of intracerebral hemorrhage symptom onset (if the patient is randomized to statin group)\n* Written informed consent\n\nExclusion Criteria:\n\n* Presence of intraventricular hemorrhage or subarachnoid hemorrhage\n* Planned surgical hematoma evacuation by open craniotomy prior to randomization (planned minimally invasive surgery is not a contraindication to enrollment)\n* Suspected secondary intracerebral hemorrhage related to trauma, tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, Moyamoya disease, or venous sinus thrombosis\n* Unable to swallow a statin pill and have contraindication to position a nasogastric tube\n* Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST), or alanine aminotransferase (ALT) ≥2 × the upper limit of normal\n* Known pregnancy, or positive pregnancy test, or breastfeeding\n* Other diseases or abnormalities that the investigator believed might compromise the patient's safety during the study\n* Historical modified Rankin scale score ≥2\n* Life expectancy of less than 7 days\n* Participation in another clinical study within 30 days prior to screening for the present study\n* Prior use of statins within 1 month before intracerebral hemorrhage"}, 'identificationModule': {'nctId': 'NCT04857632', 'acronym': 'STATIC', 'briefTitle': 'Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage', 'orgStudyIdInfo': {'id': 'STATIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Statins group', 'interventionNames': ['Drug: Statin']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Statin', 'type': 'DRUG', 'description': 'atorvastatin 20mg per day for 7 days', 'armGroupLabels': ['Statins group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Daiquan Gao, M.D.', 'role': 'CONTACT'}], 'facility': 'Beijing Fengtai Youanmen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xunming ji', 'role': 'CONTACT', 'email': 'jixunming@vip.163.com', 'phone': '861013120136877'}], 'facility': 'Xuan Wu Hospital，Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Baoding', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shijie Bao', 'role': 'CONTACT'}], 'facility': 'Hebei Province Shunping County Hospital', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}], 'centralContacts': [{'name': 'Chuanjie Wu, Dr.', 'role': 'CONTACT', 'email': 'wuchuanjie8557@163.com', 'phone': '18911366882'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ji Xunming,MD,PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}