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| Name | Class |
|---|---|
| Korea Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilostazol+ Probucol | Experimental | 100mg cilostazol bid plus probucol plus placebo of aspirin |
|
| Aspirin + Probucol | Active Comparator | aspirin plus placebo cilostazol plus probucol |
|
| Cilostazol | Experimental | cilostazol plus placebo of aspirin |
|
| Aspirin | Active Comparator | aspirin plus placebo of cilostazol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cilostazol | Drug | Cilostazol 100mg bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean carotid IMT progression | Annualized rate of change in mean common carotid intimal-medial thickness | one year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun U Kwon, MD,PhD | Department of Neurology, Asan Medical Center | Principal Investigator |
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| Probucol | Drug | Probucol 250mg bid |
|
|
| Aspirin | Drug | Aspirin 100mg qd |
|
| placebo of cilostazol | Drug | same shape and size of active cilostazol |
|
| Placebo of aspirin | Drug | same size and shape of active aspirin 100mg |
|
| Intima-medial thickness | Device | ultrasound measured IMT of both common carotid arteries |
|
|
| one year |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D020300 | Intracranial Hemorrhages |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
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| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| D011341 | Probucol |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
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