Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 6:17 PM
Study NCT ID:
NCT07088250
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Statins for Treatment of Primary Intracerebral Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-20', 'studyFirstSubmitDate': '2025-07-20', 'studyFirstSubmitQcDate': '2025-07-20', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Recurrent intracerebral hemorrhage', 'timeFrame': '90 ± 7 days', 'description': 'The incidence of recurrent intracerebral hemorrhage within 90 ± 7 days'}, {'measure': 'All cause mortality', 'timeFrame': '90 ± 7 days', 'description': 'All cause mortality at 90 ± 7 days.'}, {'measure': 'Any adverse event/serious adverse event', 'timeFrame': '90 ± 7 days', 'description': 'Any adverse events or serious adverse events occurred within 90 ± 7 days'}], 'primaryOutcomes': [{'measure': 'Poor functional outcome', 'timeFrame': '90 ± 7 days', 'description': 'The proportion of poor functional outcome, defined as a modified Rankin Scale (mRS) score of 4-6 at 90 ± 7 days. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'Functional independence', 'timeFrame': '90 ± 7 days', 'description': 'The proportion of functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 at 90 ± 7 days. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.'}, {'measure': 'Ordinal distribution of mRS', 'timeFrame': '90 ± 7 days', 'description': 'Ordinal distribution of the modified Rankin Scale (mRS) at 90 ± 7 days. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes'}, {'measure': 'Changes in hematoma volume from baseline to 24 ± 12 hours', 'timeFrame': '24 ± 12 hours', 'description': 'Absolute and relative changes in hematoma volume, measured as the difference between baseline CT scan and follow-up CT scan performed at 24 ± 12 hours post-baseline.'}, {'measure': 'Changes in hematoma volume from baseline to 7 ± 1 days', 'timeFrame': '7 ± 1 days', 'description': 'Absolute and relative changes in hematoma volume, measured as the difference between baseline CT scan and follow-up CT scan performed at 7 ± 1 days post-baseline.'}, {'measure': 'Changes in hematoma volume from 24 ± 12 hours to 7 ± 1 days', 'timeFrame': 'between 24 ± 12 hours and 7 ± 1 days', 'description': 'Absolute and relative changes in hematoma volume, measured as the difference between 24 ± 12 hours CT scan and 7 ± 1 days CT scan.'}, {'measure': 'Changes in perihematomal edema (PHE) volume from baseline to 7 ± 1 days', 'timeFrame': '7 ± 1 days', 'description': 'Changes in PHE volume, measured as the difference between baseline CT scan and follow-up CT scan performed at 7 ± 1 days post-baseline.'}, {'measure': 'Changes in perihematomal edema (PHE) volume from 24 ± 12 hours to 7 ± 1 days', 'timeFrame': '7 ± 1 days', 'description': 'Changes in PHE volume, measured as the difference between 24 ± 12 hours CT scan and 7 ± 1 days CT scan'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intracerebral hemorrhage', 'Treatment', 'Atorvastatin', 'Outcome'], 'conditions': ['Cerebrovascular Disorders', 'Intracranial Hemorrhages', 'Intracranial Hemorrhage', 'Intracerebral Haemorrhage']}, 'descriptionModule': {'briefSummary': 'The STOP ICH trial is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study designed to assess the efficacy and safety of atorvastatin in patients with intracerebral hemorrhage (ICH) presenting within 3 to 24 hours of symptom onset.', 'detailedDescription': 'This study is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) clinical trial aimed at evaluating the efficacy and safety of atorvastatin in patients with spontaneous intracerebral hemorrhage (ICH). Eligible participants include adults aged 18 to 80 years presenting with spontaneous ICH who are enrolled within 3 to 24 hours from symptom onset or the last known well time, provided they meet all inclusion criteria and no exclusion criteria. A total of 264 patients will be randomized in a 1:1 ratio into two treatment arms: the control group, receiving best medical treatment (BMT) in accordance with current ICH guidelines, and the experimental group, receiving BMT plus atorvastatin at a dosage of 20 mg once daily for 21 consecutive days. The primary objective is to determine whether atorvastatin improves clinical outcomes in patients with ICH. The primary efficacy endpoint is the proportion of patients with a poor functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 4 to 6.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of spontaneous intracerebral hemorrhage (ICH) confirmed by computed tomography (CT);\n* Age 18-80 years;\n* Hematoma located in the supratentorial region;\n* Time from symptom onset or last known well to baseline CT ranging from 3 to 24 hours;\n* Atorvastatin treatment can be initiated within 48 hours of symptom onset or last known well;\n* Glasgow Coma Scale (GCS) score ≥9;\n* Baseline hematoma volume of 5-35 mL;\n* Signed informed consent obtained.\n\nExclusion Criteria:\n\n* ICH secondary to trauma, tumor, aneurysm, arteriovenous malformation (AVM), vascular anomaly, hemorrhagic transformation of infarction, cerebral venous thrombosis, or anticoagulant-related ICH;\n* Patients who have undergone or are scheduled for immediate surgical intervention;\n* Pregnancy or lactation;\n* Use of oral anticoagulants within 1 month prior to symptom onset;\n* Pre-stroke mRS \\>1;\n* Known allergy to statins, active liver disease, liver dysfunction, or rhabdomyolysis;\n* Known terminal illness with a pre-stroke life expectancy of less than three months, or patients with planned withdrawal of care.'}, 'identificationModule': {'nctId': 'NCT07088250', 'acronym': 'STOP ICH', 'briefTitle': 'Statins for Treatment of Primary Intracerebral Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Anhui Medical University'}, 'officialTitle': 'Statins for Treatment Of Primary IntraCerebral Hemorrhage (STOP ICH)', 'orgStudyIdInfo': {'id': 'YX2023-041(F1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atorvastatin Treatment plus Best Medical Treatment', 'description': 'Patients in this group will receive atorvastatin treatment plus best medical treatment.', 'interventionNames': ['Drug: Atorvastatin Treatment', 'Other: Best Medical Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Best Medical Treatment', 'description': 'Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.', 'interventionNames': ['Other: Best Medical Treatment']}], 'interventions': [{'name': 'Atorvastatin Treatment', 'type': 'DRUG', 'description': 'Atorvastatin 20 mg once daily for 21 days.', 'armGroupLabels': ['Atorvastatin Treatment plus Best Medical Treatment']}, {'name': 'Best Medical Treatment', 'type': 'OTHER', 'description': 'Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.', 'armGroupLabels': ['Atorvastatin Treatment plus Best Medical Treatment', 'Best Medical Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anqing', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liangbing Zhang', 'role': 'CONTACT', 'email': 'liangbingzhang@163.com', 'phone': '15155493196'}], 'facility': "Anqing First People's Hospital of Anhui Province", 'geoPoint': {'lat': 30.51365, 'lon': 117.04723}}, {'city': 'Fuyang', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dawei Han', 'role': 'CONTACT', 'email': 'handawei980047@sina.com', 'phone': '13855896794'}], 'facility': "Fuyang City Sixth People's Hospital", 'geoPoint': {'lat': 32.9, 'lon': 115.81667}}, {'city': 'Fuyang', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zongjin Yun', 'role': 'CONTACT', 'email': 'yzjlove521@sohu.com', 'phone': '13955896560'}], 'facility': 'Fuyang Hospital of Anhui Medical University', 'geoPoint': {'lat': 32.9, 'lon': 115.81667}}, {'city': 'Fuyang', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhibo Gao', 'role': 'CONTACT', 'email': 'gzb688@126.com', 'phone': '15215689898'}], 'facility': "Fuyang People's Hospital", 'geoPoint': {'lat': 32.9, 'lon': 115.81667}}, {'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shumei Wu', 'role': 'CONTACT', 'email': 'elfinwsm@sina.com', 'phone': '13856597670'}], 'facility': "Hefei Eighth People's Hospital", 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Ye', 'role': 'CONTACT', 'email': 'yeliaa@126.com', 'phone': '0551-62183884'}], 'facility': "Hefei First People's Hospital", 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Li', 'role': 'CONTACT', 'email': 'qili_md@126.com', 'phone': '+8618623511778'}, {'name': 'Qi Li', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Huainan', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ke He', 'role': 'CONTACT', 'email': '765188944@qq.com', 'phone': '15255429870'}], 'facility': 'Huainan Xinhua Hospital', 'geoPoint': {'lat': 32.62639, 'lon': 116.99694}}, {'city': 'Huainan', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chuanqing Yu', 'role': 'CONTACT', 'email': 'yuchuanqin1967@163.com', 'phone': '18949669880'}], 'facility': "The First Affiliated Hospital of Anhui University of Science and Technology (Huainan First People's Hospital)", 'geoPoint': {'lat': 32.62639, 'lon': 116.99694}}, {'city': "Lu'an", 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weixiang Tian', 'role': 'CONTACT', 'email': '1015685276@qq.com', 'phone': '13305648455'}], 'facility': "Huoqiu First People's Hospital", 'geoPoint': {'lat': 31.73561, 'lon': 116.51688}}, {'city': "Lu'an", 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianshang Wen', 'role': 'CONTACT', 'email': 'wjs916@126.com', 'phone': '13956145900'}], 'facility': "Shucheng People's Hospital", 'geoPoint': {'lat': 31.73561, 'lon': 116.51688}}, {'city': 'Suzhou', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoqiang Wu', 'role': 'CONTACT', 'email': 'Wxq121@163.com', 'phone': '05577010396'}], 'facility': "Si County People's Hospital", 'geoPoint': {'lat': 33.63611, 'lon': 116.97889}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongsheng Liang', 'role': 'CONTACT', 'email': 'lianghongsheng@hrbmu.edu.cn', 'phone': '13339318226'}], 'facility': 'The First Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Kaifeng', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinsheng Han', 'role': 'CONTACT', 'email': 'hansong2008@126.com', 'phone': '18603780505'}], 'facility': 'Kaifeng Central Hospital', 'geoPoint': {'lat': 34.7986, 'lon': 114.30742}}, {'city': 'Zhoukou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chaoqun Li', 'role': 'CONTACT', 'email': '568258977@qq.com', 'phone': '0394-2551384'}], 'facility': "Xihua County People's Hospital", 'geoPoint': {'lat': 33.63333, 'lon': 114.63333}}, {'city': 'Xiangyang', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jincheng Liu', 'role': 'CONTACT', 'email': 'liujincheng004@163.com', 'phone': '0710-3444963'}], 'facility': 'Xiangyang Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 32.0422, 'lon': 112.14479}}, {'city': 'Chenzhou', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Xu', 'role': 'CONTACT', 'email': '364244173@qq.com', 'phone': '18873586687'}], 'facility': "The First People's Hospital of Chenzhou", 'geoPoint': {'lat': 25.8, 'lon': 113.03333}}, {'city': 'Yancheng', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guojun He', 'role': 'CONTACT', 'email': 'heguojun@ycsyy.com', 'phone': '15251131959'}], 'facility': "Yancheng First People's Hospital", 'geoPoint': {'lat': 33.3575, 'lon': 120.1573}}, {'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Songge Zhang', 'role': 'CONTACT', 'email': '920992308@qq.com', 'phone': '13708239928'}], 'facility': 'Chengdu Western Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Panzhihua', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenyu Zhang', 'role': 'CONTACT', 'email': '1006298426@qq.com', 'phone': '0812-2238461'}], 'facility': 'Panzhihua Central Hospital', 'geoPoint': {'lat': 26.58509, 'lon': 101.71276}}, {'city': 'Dazhou', 'state': 'Sizhuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sheng Zhu', 'role': 'CONTACT', 'email': '37177343@qq.com', 'phone': '08186096301'}], 'facility': "Dazhu County People's Hospital", 'geoPoint': {'lat': 31.2106, 'lon': 107.46308}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Cheng', 'role': 'CONTACT', 'email': '1096497150@qq.com', 'phone': '023-89011876'}], 'facility': 'The Third Affiliated Hospital of Chong Qing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Qi Li', 'role': 'CONTACT', 'email': 'qili_md@126.com', 'phone': '+8618623511778'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Anhui Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qi Li', 'investigatorAffiliation': 'The Second Hospital of Anhui Medical University'}}}}