Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-28 @ 9:32 PM
Study NCT ID:
NCT00487461
Status:
TERMINATED
Last Update Posted:
2015-11-25
First Post:
2007-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D020301', 'term': 'Vasospasm, Intracranial'}], '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': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alaraj@uic.edu', 'phone': '312-996-4842', 'title': 'Ali Alaraj, MD', 'organization': 'University of Illinois at Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed and Primary Physician leaving institution before study completion.'}}, 'adverseEventsModule': {'description': 'Serious and Other (Not Including Serious) Adverse Events were not collected/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Placebo tablet\n\nPlacebo: Placebo tablet', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Study Group #1', 'description': 'Simvastatin 40 mg\n\nSimvastatin: Comparing two doses of Simvastatin to placebo', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Study Group #2', 'description': 'Simvastatin 80 mg\n\nSimvastatin: Comparing two doses of Simvastatin to placebo', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Placebo tablet\n\nPlacebo: Placebo tablet'}, {'id': 'OG001', 'title': 'Study Group #1', 'description': 'Simvastatin 40 mg\n\nSimvastatin: Comparing two doses of Simvastatin to placebo'}, {'id': 'OG002', 'title': 'Study Group #2', 'description': 'Simvastatin 80 mg\n\nSimvastatin: Comparing two doses of Simvastatin to placebo'}], 'timeFrame': '21 days', 'reportingStatus': 'POSTED', 'populationDescription': 'Study PI left before outcome data was collected for the study and therefore the Outcome(s) will never be analyzed.'}, {'type': 'SECONDARY', 'title': 'To Determine Efficiency of Simvastatin in Decreasing the Incidence of Clinical Vasospasm in aSAH, and Define the Optimal Dose of Simvastatin and to Measure Outcome at 6 Months Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Placebo tablet\n\nPlacebo: Placebo tablet'}, {'id': 'OG001', 'title': 'Study Group #1', 'description': 'Simvastatin 40 mg\n\nSimvastatin: Comparing two doses of Simvastatin to placebo'}, {'id': 'OG002', 'title': 'Study Group #2', 'description': 'Simvastatin 80 mg\n\nSimvastatin: Comparing two doses of Simvastatin to placebo'}], 'timeFrame': '6 months', 'description': 'Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Placebo tablet\n\nPlacebo: Placebo tablet'}, {'id': 'FG001', 'title': 'Study Group #1', 'description': 'Simvastatin 40 mg\n\nSimvastatin: Comparing two doses of Simvastatin to placebo'}, {'id': 'FG002', 'title': 'Study Group #2', 'description': 'Simvastatin 80 mg\n\nSimvastatin: Comparing two doses of Simvastatin to placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Placebo tablet\n\nPlacebo: Placebo tablet'}, {'id': 'BG001', 'title': 'Study Group #1', 'description': 'Simvastatin 40 mg\n\nSimvastatin: Comparing two doses of Simvastatin to placebo'}, {'id': 'BG002', 'title': 'Study Group #2', 'description': 'Simvastatin 80 mg\n\nSimvastatin: Comparing two doses of Simvastatin to placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '47', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '50', 'spread': '11.6', 'groupId': 'BG002'}, {'value': '49', 'spread': '10.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '> 70 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': '60-70 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': '50-60 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': '40-50 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': '< 40 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'Study PI left the institution and study was stopped at that time.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-22', 'studyFirstSubmitDate': '2007-06-15', 'resultsFirstSubmitDate': '2015-07-22', 'studyFirstSubmitQcDate': '2007-06-15', 'lastUpdatePostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-22', 'studyFirstPostDateStruct': {'date': '2007-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH', 'timeFrame': '21 days'}], 'secondaryOutcomes': [{'measure': 'To Determine Efficiency of Simvastatin in Decreasing the Incidence of Clinical Vasospasm in aSAH, and Define the Optimal Dose of Simvastatin and to Measure Outcome at 6 Months Follow up', 'timeFrame': '6 months', 'description': 'Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SAH', 'Vasospasm'], 'conditions': ['Aneurysmal Subarachnoid Hemorrhage', 'Cerebral Vasospasm']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether treatment with a drug called Simvastatin prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is currently approved for the treatment of high cholesterol levels.', 'detailedDescription': 'Aneurysmal Subarachnoid hemorrhage or SAH (bleeding on the surface of the brain) affects 10 per 100,000 population each year. For survivors of the initial hemorrhage, delayed narrowing of the blood vessels (vasospasm) and related delayed strokes are the most common serious complication. Narrowing of blood vessels affect 30% of patients with such bleeding. Despite maximum therapy, nearly 50% of patients with symptomatic vasospasm with develop stroke. Because cerebral vasospasm remains the leading cause of morbidity and mortality after aSAH, this critically important issue needs further studies.\n\nOne hundred and fifty patients will be randomized, 50 to each arm of the study. Patients enrolled in the study will be receive the drug (either Simvastatin 40 mg or Simvastatin 80 mg per mouth daily), while the control group will receive a sugar tablet. The treatment will be continued for a total of 21 days. The neurological abilities (Stroke Outcome measures, these are included with the application for your review) at day 21 post aSAH will be reviewed at time of discharge as well at 6 months of follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-85 years old inclusive\n* Subarachnoid hemorrhage diagnosed by CT on admission\n* Randomizable within 732 hours of subarachnoid hemorrhage\n* Saccular intracranial aneurysm proven by cerebral angiography or computed tomographic angiography (CTA)\n* Surgical or endovascular obliteration\n* Able to obtain written informed consent from patient or surrogate\n\nExclusion Criteria:\n\n* Pregnancy, as confirmed by routine urine test on admission\n* Elevated liver function test at time of randomization, defined as more than three times the upper limit of normal\n* On Statins, niacin, or fibrate therapy within 30 days of presentation\n* Any vasospasm on the initial diagnostic angiogram\n* Glasgow Coma Scale 5 or less at the time of randomization\n* History of liver disease or active liver disease\n* Hypersensitivity to statins\n* Patient taking medication not recommended for concomitant use with Simvastatin (40 or 80 mg) as per the product label'}, 'identificationModule': {'nctId': 'NCT00487461', 'briefTitle': 'Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Randomized Double Blind Study Using Simvastatin for the PRevention Aof Vasospasm in Aneurysmal Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': '2005-0857'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Placebo tablet', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Study Group #1', 'description': 'Simvastatin 40 mg', 'interventionNames': ['Drug: Simvastatin 40 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Study Group #2', 'description': 'Simvastatin 80 mg', 'interventionNames': ['Drug: Simvastatin 80 mg']}], 'interventions': [{'name': 'Simvastatin 40 mg', 'type': 'DRUG', 'otherNames': ['Zocor'], 'description': 'Comparing two doses of Simvastatin to placebo', 'armGroupLabels': ['Study Group #1']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['dummy pill, sugar pill'], 'description': 'Placebo tablet', 'armGroupLabels': ['Control Group']}, {'name': 'Simvastatin 80 mg', 'type': 'DRUG', 'otherNames': ['Zocor'], 'description': 'Comparing two doses of Simvastatin to placebo', 'armGroupLabels': ['Study Group #2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Univeristy of Illinois at Chicago, Dept of Neurosurgery', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Ben Z. Roitberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assnt Prof. Univ. of Illinois at Chicago, Dept of Neurosurgery'}, {'name': 'Ali Alaraj, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Fellow Department of Neurosurgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ali Alaraj', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}