PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study

Study Overview
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Brief Summary
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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. 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.

Official Title
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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

Conditions
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Brain Ischemia, Intracranial Hemorrhages

Intervention / Treatment
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* Drug: cilostazol
* Drug: Probucol
* Drug: Aspirin
* Drug: placebo of cilostazol
* Drug: Placebo of aspirin
* Device: Intima-medial thickness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of ischemic stroke within 120 days 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: Clinical diagnosis of myocardial infarction or coronary intervention within 4 weeks 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cilostazol+ Probucol<br>100mg cilostazol bid plus probucol plus placebo of aspirin | Drug: cilostazol<br>* Cilostazol 100mg bid<br>* Other names: Pletaal produced by Korea Otsuka Pharmaceutical company;Drug: Probucol<br>* Probucol 250mg bid<br>* Other names: Probucol is produced by Otsuka Pharmaceutical;Drug: Placebo of aspirin<br>* same size and shape of active aspirin 100mg<br>Device: Intima-medial thickness<br>* ultrasound measured IMT of both common carotid arteries<br>* Other names: - Annualized change of carotid plaque score;|
| Active Comparator: Aspirin + Probucol<br>aspirin plus placebo cilostazol plus probucol | Drug: Probucol<br>* Probucol 250mg bid<br>* Other names: Probucol is produced by Otsuka Pharmaceutical;Drug: Aspirin<br>* Aspirin 100mg qd<br>Drug: placebo of cilostazol<br>* same shape and size of active cilostazol<br>Device: Intima-medial thickness<br>* ultrasound measured IMT of both common carotid arteries<br>* Other names: - Annualized change of carotid plaque score;|
| Experimental: Cilostazol<br>cilostazol plus placebo of aspirin | Drug: cilostazol<br>* Cilostazol 100mg bid<br>* Other names: Pletaal produced by Korea Otsuka Pharmaceutical company;Drug: Placebo of aspirin<br>* same size and shape of active aspirin 100mg<br>Device: Intima-medial thickness<br>* ultrasound measured IMT of both common carotid arteries<br>* Other names: - Annualized change of carotid plaque score;|
| Active Comparator: Aspirin<br>aspirin plus placebo of cilostazol | Drug: Aspirin<br>* Aspirin 100mg qd<br>Drug: placebo of cilostazol<br>* same shape and size of active cilostazol<br>Device: Intima-medial thickness<br>* ultrasound measured IMT of both common carotid arteries<br>* Other names: - Annualized change of carotid plaque score;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean carotid IMT progression | Annualized rate of change in mean common carotid intimal-medial thickness | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum carotid IMT progression | annualized rate of change in maximal carotid intimal-medial thickness | one year | 
| carotid plaque score | annualized change of carotid plaque score | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, intracranial hemorrhage, cilostazol, probucol, intima media thickness