Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-03-05 @ 3:31 AM
Study NCT ID:
NCT01872858
Status:
UNKNOWN
Last Update Posted:
2013-06-07
First Post:
2013-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Cilostazol in Patients of Vascular Cognitive Impairment-no Dementia (VCIND)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077407', 'term': 'Cilostazol'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-05', 'studyFirstSubmitDate': '2013-06-05', 'studyFirstSubmitQcDate': '2013-06-05', 'lastUpdatePostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in cognitive function', 'timeFrame': 'baseline, 3month, 6month, 1year, and 2year', 'description': 'scores in Montreal Cognitive Assessment，Mini-Mental Status Examination, Clinal Dementia Rating，trail making test, similarity test, Stroop test.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Incident cerebral vascular event', 'timeFrame': '3month, 6month, 1year and 2year', 'description': 'including cerebral infarct, cerebral hemorrhage, transient ischemic attack.'}, {'measure': 'Changes of peripheral inflammatory markers level', 'timeFrame': 'baseline, 2year', 'description': 'intercellular adhesion molecules(ICAM), thrombomodulin, tissue factor(TF), tissue factor plasma inhibitor，TFPI, etc.'}, {'measure': 'The progression of cerebral white matter lesion and lacunar infarction', 'timeFrame': 'baseline, 3month, 6month, 1year and 2year'}, {'measure': 'changes in MRI-diffused tension image(DTI)', 'timeFrame': 'baseline, 2year', 'description': 'cerebral volume , lacune infarct, white matter lesion, micro-bleed, apparent diffusion coefficient(ADC) .'}]}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'Patients of vascular cognitive impairment-no dementia (VCIND) in one group is prescribed cilostazol,in the other group is prescribed aspirin. Evaluate both of them in cognitive function, MRI and other sides at given time. The investigators hypothesize that cilostazol is more efficient and safer than aspirin in patients with VCIND.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged between 50-80, both gender；\n2. Small vessel disease and associated cognitive impairment, diagnosed as VCIND；\n3. Non-specific subjective symptoms (dizziness, somnolence, numbness in limbs) are acceptable.\n4. Normal hepatic and renal function.\n5. With good compliance.\n\nExclusion Criteria:\n\n1. Aged above 80 or less than 50.\n2. Dementia.\n3. Cerebral infarction(\\>2cm).\n4. Major vascular lesion. (stenosis\\>50%).\n5. Cardiac cerebral infarction.\n6. Intracerebral Hemorrhage.\n7. Clinical manifestations cannot attribute to small vessel disease.\n8. Major depression or dysfunction in speech, visual ability, hearing or aphasia that would interfere with the cognitive assessment.\n9. Severe systematic organic impairment(cardiac, hepatic, renal dysfunction).\n10. Thrombocytopenic Purpura.\n11. History of hemorrhage in digestive system or surgery in past 3 months.\n12. Previously on cilostazol treatment for more than 3 month.\n13. Allergic to aspirin or cilostazol.\n14. Enrolled in other clinical trials in past 3 months.\n15. Lack of informed consent or compliance.\n16. Contraindications for MRI scan.'}, 'identificationModule': {'nctId': 'NCT01872858', 'briefTitle': 'Efficacy and Safety of Cilostazol in Patients of Vascular Cognitive Impairment-no Dementia (VCIND)', 'nctIdAliases': ['NCT01862575'], 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'orgStudyIdInfo': {'id': 'jianhuifu2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin', 'description': 'Aspirin, 100mg, Q.D, p.o, 2yr', 'interventionNames': ['Drug: Aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Cilostazol', 'description': 'cilostazol, 100mg, B.I.D, p.o, 2yr', 'interventionNames': ['Drug: Cilostazol']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'description': 'Aspirin, 100mg, Q.D, p.o, 2yr', 'armGroupLabels': ['Aspirin']}, {'name': 'Cilostazol', 'type': 'DRUG', 'description': 'cilostazol, 100mg, B.I.D, p.o, 2yr', 'armGroupLabels': ['Cilostazol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Tang', 'role': 'CONTACT', 'email': 'tan11711@hotmail.com', 'phone': '+8618818210880'}], 'facility': 'Dept. of Neurology, Huashan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Neurology, Huashan Hospital', 'investigatorFullName': 'Jianhui Fu', 'investigatorAffiliation': 'Huashan Hospital'}}}}