Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT02846259
Status:
UNKNOWN
Last Update Posted:
2016-11-10
First Post:
2016-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Benefit and Risk of Oral Aspirin for Unruptured Intracranial Aneurysm Combined With Cerebral Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D002545', 'term': 'Brain Ischemia'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2135}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-09', 'studyFirstSubmitDate': '2016-07-25', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aneurysm rupture hemorrhage', 'timeFrame': '2 years during the follow-up period', 'description': 'Aneurysm subarachnoid hemorrhage without trauma'}], 'secondaryOutcomes': [{'measure': 'TIA', 'timeFrame': '2 years during the follow-up period'}, {'measure': 'Aneurysm changing', 'timeFrame': '2 years during the follow-up period', 'description': 'the aneurysm becomes bigger, its form changes, becomes two or more'}, {'measure': 'dead', 'timeFrame': '2 years during the follow-up period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intracranial aneurysm', 'cerebral ischemia', 'aspirin'], 'conditions': ['Intracranial Aneurysm', 'Cerebral Ischemia']}, 'referencesModule': {'references': [{'pmid': '33953800', 'type': 'DERIVED', 'citation': 'Wang J, Weng J, Li H, Jiao Y, Fu W, Huo R, Yan Z, Xu H, Zhan J, Wang S, Du X, Cao Y, Zhao J. Atorvastatin and growth, rupture of small unruptured intracranial aneurysm: results of a prospective cohort study. Ther Adv Neurol Disord. 2021 Apr 9;14:1756286420987939. doi: 10.1177/1756286420987939. eCollection 2021.'}, {'pmid': '33055274', 'type': 'DERIVED', 'citation': 'Weng JC, Wang J, Du X, Li H, Jiao YM, Fu WL, Huo R, Yan ZH, Xu HY, Wang S, Cao Y, Zhao JZ; Small Unruptured Aneurysms Study Group. Safety of Aspirin Use in Patients With Stroke and Small Unruptured Aneurysms. Neurology. 2021 Jan 5;96(1):e19-e29. doi: 10.1212/WNL.0000000000010997. Epub 2020 Oct 14.'}, {'pmid': '32878566', 'type': 'DERIVED', 'citation': 'Weng JC, Wang J, Li H, Jiao YM, Fu WL, Huo R, Yan ZH, Xu HY, Zhan J, Wang S, Du X, Cao Y, Zhao JZ; Small Unruptured Aneurysms Study Group. Aspirin and Growth of Small Unruptured Intracranial Aneurysm: Results of a Prospective Cohort Study. Stroke. 2020 Oct;51(10):3045-3054. doi: 10.1161/STROKEAHA.120.029967. Epub 2020 Sep 3.'}]}, 'descriptionModule': {'briefSummary': "The first purpose of this study is to find out the clinical benefit and risk of oral aspirin for unruptured intracranial aneurysm (small than 7mm) combined with cerebral ischemia in patients in the real world.\n\nThe second purpose of this study is to get the prediction model of aneurysm's rupture in patients who has unruptured intracranial aneurysm (small than 7mm) combined with cerebral ischemia , and find out who is suitable for oral aspirin.", 'detailedDescription': 'The investigators try to collect the information of the patients have unruptured intracranial aneurysm combined with cerebral ischemia when oral aspirin.The characteristics of this study are large sample, multi center and prospective.In the real world, more and more patients are checked out unruptured intracranial aneurysm combined with cerebral ischemia.The investigators can collect the information such as how they use aspirin (dose, frequency, duration of treatment), demographic information, past history, daily life habits, morphological characteristics of the aneurysm, how they use other antithrombotic drugs.The investigators will record whether the aneurysm ruptured and have hemorrhage, ischemic stroke, death, changes in the morphology of aneurysm, MRI permeability image index changes. Finally the investigators will get the clinical benefits and risks of using aspirin and build the prediction model of rupture and hemorrhage for aneurysm, find out who is suitable for oral aspirin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators chose the patiens from the Tiantan hospital and other hospitals that participated in this study.The patients will all have unruptured intracranial aneurysm with the history of cerebral ischemia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. has the diagnosis of unruptured intracranial aneurysm (using the CTA/DSA,smaller than 7mm)\n2. has the history of TIA or any other diseases of cerebral ischemia\n3. older than 18 years old\n4. sign the informed consent\n\nExclusion Criteria:\n\n1. has the history of intracranial aneurysm rupture hemorrhage or has more than one aneurysm untreated\n2. has a family history of intracranial aneurysm\n3. has AVM，MMD, intracranial tumor, hydrocephalus or intracranial hemorrhage\n4. refuse to sign the informed consent\n5. allergic to contrast medium'}, 'identificationModule': {'nctId': 'NCT02846259', 'acronym': 'CBROAUNACCI', 'briefTitle': 'The Clinical Benefit and Risk of Oral Aspirin for Unruptured Intracranial Aneurysm Combined With Cerebral Ischemia', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'The Clinical Benefit and Risk of Oral Aspirin for Patients Who Have Unruptured Intracranial Aneurysm Combined With Cerebral Ischemia', 'orgStudyIdInfo': {'id': 'SKW2016-13-aspirin'}}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Cao, M.D.', 'role': 'CONTACT', 'email': 'caoyong6@hotmail.com', 'phone': '010-67096523', 'phoneExt': '100050'}, {'name': 'Yong Cao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yong Cao, M.D.', 'role': 'CONTACT', 'email': 'caoyong6@hotmail.com', 'phone': '010-67096523', 'phoneExt': '100050'}], 'overallOfficials': [{'name': 'Yong Cao', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, {'name': 'The Second Hospital of Hebei Medical University', 'class': 'OTHER'}, {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, {'name': 'Tianjin Huanhu Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal', 'investigatorFullName': 'Dr. Yong Cao', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}