Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-30 @ 3:10 AM
Study NCT ID:
NCT01932203
Status:
UNKNOWN
Last Update Posted:
2019-08-08
First Post:
2013-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D049292', 'term': 'Leukoaraiosis'}], 'ancestors': [{'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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2013-08-27', 'studyFirstSubmitQcDate': '2013-08-27', 'lastUpdatePostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'All ischemic stroke event', 'timeFrame': 'week 104', 'description': 'cerebral infarction and transient ischemic attack'}, {'measure': 'All vascular events', 'timeFrame': 'week 104', 'description': 'including ischemic stroke, transient ischemic attack, myocardial infarction, angina pectoris, cerebral venous thrombosis, pulmonary embolism, symptomatic deep vein thrombosis, symptomatic peripheral artery occlusion, other vascular occlusion, and any revascularization procedure'}], 'primaryOutcomes': [{'measure': 'Volume of white matter changes (WMCs)', 'timeFrame': 'baseline, week 104', 'description': 'Measure change of WMC on brain MRI'}], 'secondaryOutcomes': [{'measure': 'Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging', 'timeFrame': 'baseline and week 104', 'description': 'High MD and low FA means tissue damage.'}, {'measure': 'Number of lacunes', 'timeFrame': 'baseline and week 104', 'description': 'High number means tissue damage.'}, {'measure': 'number of microbleeds', 'timeFrame': 'baseline and week 104', 'description': 'High number means tissue damage.'}, {'measure': 'brain volume and cortical thickness', 'timeFrame': 'baseline and week 104', 'description': 'Low score means tissue damage.'}, {'measure': 'Mini-Mental State Examination', 'timeFrame': 'baseline, week 52, and week 104', 'description': 'Measure global cognition. Score range is 0-30. Higher score means good cognition.'}, {'measure': 'Neurocognitive test', 'timeFrame': 'baseline, week 52, and week 104', 'description': 'Seoul Verbal Learning Test, Boston Naming test-short form, ROCF copy, animal fluency, phonemic fluency, Stroop test, Digit-symbol test, Trail making test'}, {'measure': 'Clinical Dementia Rating scale-sum of boxes', 'timeFrame': 'baseline, week 52, and week 104', 'description': 'Measure global cognition. Score range is 0-18. Higher score means good cognition.'}, {'measure': "King's Health Questionnaire", 'timeFrame': 'baseline, week 42, and week 104', 'description': 'Measure voiding function. Higher score means bad function.'}, {'measure': 'Geriatric Depression Scale-Short form', 'timeFrame': 'baseline, week 52, and week 104', 'description': 'Measure depression. Score range is 0-15. Higher score means depression.'}, {'measure': 'Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)', 'timeFrame': 'baseline, week 52, and week 104', 'description': 'Measure abnormal behavior. Score range is 0-144. Higher score means severe abnormal behavior.'}, {'measure': 'Bayer Activities of Daily Living', 'timeFrame': 'baseline, week 52, and week 104', 'description': 'Measure instrumental activities of daily living (ADL). Score range is 1-10. Higher score means bad ADL.'}, {'measure': 'Barthel Index', 'timeFrame': 'baseline, week 52, and week 104', 'description': 'Measure physical ADL. Score range is 0-20. Higher score means good physical ADL.'}, {'measure': 'Pyramidal and Extrapyramidal Scale (PEPS)', 'timeFrame': 'baseline, week 52, and week 104', 'description': 'Measure neurologic signs. Score range is 0-60. Higher score means many abnormal neurologic signs.'}, {'measure': 'Timed UP and Go (TUG) test', 'timeFrame': 'basline, week 52, and week 104', 'description': 'Measure gait. Higher score means bad gait.'}, {'measure': 'Adverse event', 'timeFrame': 'baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104', 'description': 'measure any adverse events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cerebral small vessel disease', 'Leukoaraiosis', 'Magnetic Resonance Imaging', 'Diffusion Tensor Imaging'], 'conditions': ['Cerebral Small Vessel Disease']}, 'referencesModule': {'references': [{'pmid': '35833913', 'type': 'DERIVED', 'citation': 'Kwan J, Hafdi M, Chiang LLW, Myint PK, Wong LS, Quinn TJ. Antithrombotic therapy to prevent cognitive decline in people with small vessel disease on neuroimaging but without dementia. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD012269. doi: 10.1002/14651858.CD012269.pub2.'}, {'pmid': '34781708', 'type': 'DERIVED', 'citation': 'Kim BC, Youn YC, Jeong JH, Han HJ, Kim JH, Lee JH, Park KH, Park KW, Kim EJ, Oh MS, Shim Y, Lee JM, Choi YH, Park G, Kim S, Park HY, Yoon B, Yoon SJ, Cho SJ, Park KC, Na DL, Park SA, Choi SH. Cilostazol Versus Aspirin on White Matter Changes in Cerebral Small Vessel Disease: A Randomized Controlled Trial. Stroke. 2022 Mar;53(3):698-709. doi: 10.1161/STROKEAHA.121.035766. Epub 2021 Nov 16.'}, {'pmid': '31942173', 'type': 'DERIVED', 'citation': 'Han HJ, Kim BC, Youn YC, Jeong JH, Kim JH, Lee JH, Park KH, Park KW, Kim EJ, Oh MS, Shim YS, Park HY, Yoon B, Yoon SJ, Cho SJ, Park KC, Na DL, Park SA, Lee JM, Choi SH. A Comparison Study of Cilostazol and Aspirin on Changes in Volume of Cerebral Small Vessel Disease White Matter Changes: Protocol of a Multicenter, Randomized Controlled Trial. Dement Neurocogn Disord. 2019 Dec;18(4):138-148. doi: 10.12779/dnd.2019.18.4.138. Epub 2019 Dec 13.'}]}, 'descriptionModule': {'briefSummary': 'There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.', 'detailedDescription': 'The primary objective of this study is to compare the efficacy of aspirin and cilostazol on volume of white matter changes in cerebral small vessel disease.\n\nThe secondary objectives are to compare the impact of aspirin and cilostazol on DTI parameters, lacune, microbleeds, brain atrophy, cognition, depression, neurologic signs, gait, urination, and activities of daily living.\n\nWe also investigate risk factors associated with progression of cerebral small vessel disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 50 to 85 years of age\n* He/She can walk to the hospital (walker or cane is permissible).\n* Cerebral small vessel disease is observed on brain MRI.\n\n 1\\) presence of one or more lacunar infarction and 2) moderate or severe confluent leukoaraiosis (defined as grade 2 or 3 on a modified Fazekas scale): periventricular WMCs with cap or rims lager than 5mm and deep subcortical WMCs \\>10 mm in maximum diameter\n* written informed consent\n\nExclusion Criteria:\n\n* Any patient with contraindication of antiplatelets\n* Any patient with cardioembolic source\n* Carotid bruit or large cerebral artery stenosis \\>50%\n* Cortical infarction or subcortical infarction lager than 1.5 cm\n* bleeding tendency\n* chronic liver disease (AST or ALT \\>100 IL/L)\n* chronic renal disease (Creatinine \\>3.0mg/dL)\n* active gastrointestinal ulcer\n* any patients with any severe or unstable medical disease that may prevent them from completing study requirements (i.e., unstable or severe asthma)\n* Anemia (Hb \\<10g/dL) or thrombocytopenia\n* Cardiac pacemaker or contraindication to MRI\n* Pregnancy or breast-feeding\n* drug or alcohol addiction\n* Any other white matte disease (i.e., Multiple sclerosis, sarcoidosis, or brain irradiation, etc) or brain tumor\n* Parkinson's disease, Alzheimer's disease or any other neurodegenerative disease\n* any hearing or visual impairment that can disturb the efficient evaluation of the patient\n* recent cerebral infarction with 3 months"}, 'identificationModule': {'nctId': 'NCT01932203', 'acronym': 'Challenge', 'briefTitle': 'Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Inha University Hospital'}, 'officialTitle': 'A Multicenter, Randomized, Double Blind Study to Compare the Efficacy Between Cilostazol and Aspirin on White Matter Changes by Cerebral Small Vessel Disease', 'orgStudyIdInfo': {'id': '20130006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'aspirin', 'description': 'aspirin 100mg by mouth once a day for 104 weeks', 'interventionNames': ['Drug: aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Cilostazol', 'description': 'Pletaal SR 200mg by mouth once a day for 104 weeks', 'interventionNames': ['Drug: cilostazol']}], 'interventions': [{'name': 'aspirin', 'type': 'DRUG', 'description': '100mg once a day', 'armGroupLabels': ['aspirin']}, {'name': 'cilostazol', 'type': 'DRUG', 'otherNames': ['Pletaal SR'], 'description': '200mg once a day', 'armGroupLabels': ['Cilostazol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '412-270', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Myongji Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Health Insurance Corporation Ilsan Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Hwaseong-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Dongtan Sacred Heart Hospital, Hallym University College of Medicine', 'geoPoint': {'lat': 37.20682, 'lon': 126.8169}}, {'city': 'Iksan', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Wonkwang University Iksan Hospital', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}, {'city': 'Anyang', 'country': 'South Korea', 'facility': 'Hallym University Medical Center', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Bucheon-si', 'country': 'South Korea', 'facility': "Bucheon St.Mary's Hospital", 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soonchunhyang University Bucheon Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Eulji University School of Medicine', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Konyang University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '400-711', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chungang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seong Hye Choi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inha University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inha University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Inha University Hospital', 'investigatorAffiliation': 'Inha University Hospital'}}}}