Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-02 @ 11:19 AM
Study NCT ID:
NCT02483169
Status:
UNKNOWN
Last Update Posted:
2015-12-24
First Post:
2015-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], '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': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020521', 'term': 'Stroke'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077407', 'term': 'Cilostazol'}, {'id': 'D011341', 'term': 'Probucol'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'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'}, {'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': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-23', 'studyFirstSubmitDate': '2015-06-24', 'studyFirstSubmitQcDate': '2015-06-25', 'lastUpdatePostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean carotid IMT progression', 'timeFrame': 'one year', 'description': 'Annualized rate of change in mean common carotid intimal-medial thickness'}], 'secondaryOutcomes': [{'measure': 'maximum carotid IMT progression', 'timeFrame': 'one year', 'description': 'annualized rate of change in maximal carotid intimal-medial thickness'}, {'measure': 'carotid plaque score', 'timeFrame': 'one year', 'description': 'annualized change of carotid plaque score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ischemic stroke', 'intracranial hemorrhage', 'cilostazol', 'probucol', 'intima media thickness'], 'conditions': ['Brain Ischemia', 'Intracranial Hemorrhages']}, 'descriptionModule': {'briefSummary': 'Through this study, the investigators are to prove that Cilostazol effectively prevent progression of intima-medial thickness in ischemic stroke patients with high risk of cerebral hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side effects.\n\nThe primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the progression of intima-medial thickness compared to aspirin in the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of ischemic stroke within 120 days\n* Adult aged 20 years or older\n* High risk of hemorrhagic stroke (history of intracranial hemorrhage or imaging evidence of previous intracranial hemorrhage)\n* Informed consent\n\nExclusion Criteria:\n\n* Clinical diagnosis of myocardial infarction or coronary intervention within 4 weeks\n* Bleeding tendency\n* Pregnant or breast-feeding woman\n* Hemorrhagic stroke within 6 months\n* Patient who was taking antithrombotic medication other than aspirin and does not agree to change the previous medication\n* Severe cardiovascular disease such as cardiomyopathy or congestive heart failure\n* Life expectancy less than one year\n* Contraindication to long term aspirin use\n* Enrolled in other clinical trial within 30 days'}, 'identificationModule': {'nctId': 'NCT02483169', 'acronym': 'PICASSO-IMT', 'briefTitle': 'PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Double Blind Placebo Controlled Multicenter Trial for Prevention of IMT Progression in the Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage With Cilostazol and Probucol', 'orgStudyIdInfo': {'id': 'PICASSO-IMT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cilostazol+ Probucol', 'description': '100mg cilostazol bid plus probucol plus placebo of aspirin', 'interventionNames': ['Drug: cilostazol', 'Drug: Probucol', 'Drug: Placebo of aspirin', 'Device: Intima-medial thickness']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin + Probucol', 'description': 'aspirin plus placebo cilostazol plus probucol', 'interventionNames': ['Drug: Probucol', 'Drug: Aspirin', 'Drug: placebo of cilostazol', 'Device: Intima-medial thickness']}, {'type': 'EXPERIMENTAL', 'label': 'Cilostazol', 'description': 'cilostazol plus placebo of aspirin', 'interventionNames': ['Drug: cilostazol', 'Drug: Placebo of aspirin', 'Device: Intima-medial thickness']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin', 'description': 'aspirin plus placebo of cilostazol', 'interventionNames': ['Drug: Aspirin', 'Drug: placebo of cilostazol', 'Device: Intima-medial thickness']}], 'interventions': [{'name': 'cilostazol', 'type': 'DRUG', 'otherNames': ['Pletaal produced by Korea Otsuka Pharmaceutical company'], 'description': 'Cilostazol 100mg bid', 'armGroupLabels': ['Cilostazol', 'Cilostazol+ Probucol']}, {'name': 'Probucol', 'type': 'DRUG', 'otherNames': ['Probucol is produced by Otsuka Pharmaceutical'], 'description': 'Probucol 250mg bid', 'armGroupLabels': ['Aspirin + Probucol', 'Cilostazol+ Probucol']}, {'name': 'Aspirin', 'type': 'DRUG', 'description': 'Aspirin 100mg qd', 'armGroupLabels': ['Aspirin', 'Aspirin + Probucol']}, {'name': 'placebo of cilostazol', 'type': 'DRUG', 'description': 'same shape and size of active cilostazol', 'armGroupLabels': ['Aspirin', 'Aspirin + Probucol']}, {'name': 'Placebo of aspirin', 'type': 'DRUG', 'description': 'same size and shape of active aspirin 100mg', 'armGroupLabels': ['Cilostazol', 'Cilostazol+ Probucol']}, {'name': 'Intima-medial thickness', 'type': 'DEVICE', 'otherNames': ['- Annualized change of mean and maximum common carotid intima-medial thickness', '- Annualized change of carotid plaque score'], 'description': 'ultrasound measured IMT of both common carotid arteries', 'armGroupLabels': ['Aspirin', 'Aspirin + Probucol', 'Cilostazol', 'Cilostazol+ Probucol']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sun U Kwon, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korea Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sun U. Kwon', 'investigatorAffiliation': 'Asan Medical Center'}}}}