PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study
NCT ID: NCT02483169
Last Updated: 2015-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
800 participants
INTERVENTIONAL
2009-06-30
2016-12-31
Brief Summary
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The 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Cilostazol+ Probucol
100mg cilostazol bid plus probucol plus placebo of aspirin
cilostazol
Cilostazol 100mg bid
Probucol
Probucol 250mg bid
Placebo of aspirin
same size and shape of active aspirin 100mg
Intima-medial thickness
ultrasound measured IMT of both common carotid arteries
Aspirin + Probucol
aspirin plus placebo cilostazol plus probucol
Probucol
Probucol 250mg bid
Aspirin
Aspirin 100mg qd
placebo of cilostazol
same shape and size of active cilostazol
Intima-medial thickness
ultrasound measured IMT of both common carotid arteries
Cilostazol
cilostazol plus placebo of aspirin
cilostazol
Cilostazol 100mg bid
Placebo of aspirin
same size and shape of active aspirin 100mg
Intima-medial thickness
ultrasound measured IMT of both common carotid arteries
Aspirin
aspirin plus placebo of cilostazol
Aspirin
Aspirin 100mg qd
placebo of cilostazol
same shape and size of active cilostazol
Intima-medial thickness
ultrasound measured IMT of both common carotid arteries
Interventions
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cilostazol
Cilostazol 100mg bid
Probucol
Probucol 250mg bid
Aspirin
Aspirin 100mg qd
placebo of cilostazol
same shape and size of active cilostazol
Placebo of aspirin
same size and shape of active aspirin 100mg
Intima-medial thickness
ultrasound measured IMT of both common carotid arteries
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult aged 20 years or older
* High risk of hemorrhagic stroke (history of intracranial hemorrhage or imaging evidence of previous intracranial hemorrhage)
* Informed consent
Exclusion Criteria
* Bleeding tendency
* Pregnant or breast-feeding woman
* Hemorrhagic stroke within 6 months
* Patient who was taking antithrombotic medication other than aspirin and does not agree to change the previous medication
* Severe cardiovascular disease such as cardiomyopathy or congestive heart failure
* Life expectancy less than one year
* Contraindication to long term aspirin use
* Enrolled in other clinical trial within 30 days
20 Years
ALL
No
Sponsors
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Korea Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Asan Medical Center
OTHER
Responsible Party
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Sun U. Kwon
Professor
Principal Investigators
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Sun U Kwon, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, Asan Medical Center
Other Identifiers
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PICASSO-IMT
Identifier Type: -
Identifier Source: org_study_id