Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2025-12-28 @ 3:18 PM
Study NCT ID:
NCT00364559
Status:
COMPLETED
Last Update Posted:
2009-03-26
First Post:
2006-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Rosuvastatin in Intracerebral Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D020521', 'term': 'Stroke'}], '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': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-25', 'studyFirstSubmitDate': '2006-08-14', 'studyFirstSubmitQcDate': '2006-08-14', 'lastUpdatePostDateStruct': {'date': '2009-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NIHSSº', 'timeFrame': 'basal and discharge'}], 'secondaryOutcomes': [{'measure': 'Survivor', 'timeFrame': 'within 1 month'}]}, 'conditionsModule': {'keywords': ['intracerebral hemorrhage', 'statins', 'rosuvastatin', 'stroke'], 'conditions': ['Intracerebral Hemorrhage', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '17899518', 'type': 'BACKGROUND', 'citation': 'Tapia-Perez H, Sanchez-Aguilar M, Torres-Corzo J, Rodriguez-Leyva I, Herrera-Gonzalez LB. [Statins and brain protection mechanisms]. Rev Neurol. 2007 Sep 16-30;45(6):359-64. Spanish.'}, {'pmid': '18247276', 'type': 'BACKGROUND', 'citation': 'Tapia-Perez H, Torres-Corzo J, Sanchez-Aguilar M, Gonzalez-Aguirre D, Rodriguez-Leyva I, Teniente-Sanchez AE, Gordillo-Moscoso A. [A clinical-epidemiological approximation to intracerebral hemorrhage in a Mexican hospital: analysis of factors associated to mortality]. Rev Neurol. 2008 Jan 16-31;46(2):67-72. Spanish.'}, {'pmid': '19197830', 'type': 'RESULT', 'citation': 'Tapia-Perez H, Sanchez-Aguilar M, Torres-Corzo JG, Rodriguez-Leyva I, Gonzalez-Aguirre D, Gordillo-Moscoso A, Chalita-Williams C. Use of statins for the treatment of spontaneous intracerebral hemorrhage: results of a pilot study. Cent Eur Neurosurg. 2009 Feb;70(1):15-20. doi: 10.1055/s-0028-1082064. Epub 2009 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether rosuvastatin is effective in the management of acute phase of intracerebral hemorrhage and if it impact outcome by NIHSS.', 'detailedDescription': 'The intracerebral hemorrhage (ICH) is a frequent problem of health, with high morbid-mortality. In addition it originates expensive expenses in health care systems.\n\nICH produces damage by mass effect, then by biochemical ways which are activated and they carry to secondary damage. Many studies have been conducted for explaining secondary injury, now we know there are ischemic changes related maybe with changes in cerebral flow and metabolism, in addition to activate inflammatory ways. Many drugs and measures has been ineffective for getting best outcome, without success.\n\nStatins or inhibitors of HMG CoA reductase are drugs used in dyslipidemia, frequently for reduction in LDL. Experimental and clinical studies in stroke and ICH have shown improvement in outcome. The toxicity related to statin is myopathy and hepatopathy, both with low incidence without fatal cases. Rosuvastatin has been postulated be the most powerful with longest life and toxicity similar to another statins.\n\nWe have designed this study to demonstrate if the administration of rosuvastatin in the first 24 hours and by 14 days has improvement in outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or Women \\>16 and \\< 80 years with ICH and hospital attention in less 24 hours\n* Confirmation by CT scan\n* Acceptance by family\n\nExclusion Criteria:\n\n* History of stroke\n* History of neurological disease, head injury o psychiatric disorder with disability\n* Glasgow less than 9\n* Administration 24 hours before: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem, amiodarone.\n* Use before hospital of: mannitol, barbiturates, corticosteroids, calcium antagonists\n* Any lesion which needs surgery\n* Allergy to drug used\n* cerebral death\n* Hepatic disease (Child B y C) or myopathy (or) history\n* Management in other Hospital\n* Pregnancy\n* ICH major than 60 ml.\n* hypothyroidism'}, 'identificationModule': {'nctId': 'NCT00364559', 'briefTitle': 'Effect of Rosuvastatin in Intracerebral Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de San Luis Potosí'}, 'officialTitle': 'Effect of Rosuvastatin on Outcome by NIHSS After Intracerebral Hemorrhage', 'orgStudyIdInfo': {'id': '29-09 ROICH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'A, Active B, Historical Register', 'interventionNames': ['Drug: Rosuvastatin']}], 'interventions': [{'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Crestor'], 'description': '20 mg 10 days daily', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78240', 'city': 'San Luis Potosí City', 'state': 'San Luis Potosí', 'country': 'Mexico', 'facility': 'Hospital Central "Dr. Ignacio Morones Prieto"', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}], 'overallOfficials': [{'name': 'Ildefonso Rodríguez-Leyva, Neurology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neurología, Hospital Central "Dr. ignacio Morones Prieto"'}, {'name': 'Humberto Tapia-Perez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Facultad de Medicina UASLP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de San Luis Potosí', 'class': 'OTHER'}, 'responsibleParty': {'oldOrganization': 'Humberto Tapia'}}}}