Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Korea Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Currently, aspirin plus clopidogrel is considered as a standard acute treatment of ischemic stroke, based on results of CHANCE and POINT trial. However, still a considerable portion of patients showed early stroke recurrence, especially in those with stroke due to large artery atherosclerosis. Cilostazol may have benefit in reducing early stroke recurrence of neurologic deterioriation. The post-hoc analysis of CSPS.com showed that use of cilostazol after 15 days of stroke was effective for preventing subsequent stroke. The effect of adding cilostazol was more effective in those with large artery atherosclerosis and those receiving clopidogrel than aspirin.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CA group | Experimental | Aspirin 100mg qd (21days), clopidogrel 75mg qd (180days), Cilostazol SR 100mg x 2cap (180days). In case of stenting, aspirin will be added to cilostazol and clopidogrel until 90 days after stenting. |
|
| PA group | Placebo Comparator | Aspirin 100mg (21days), clopidogrel 75mg qd (180days), Placebo x 2cap (180days). In case of stenting, aspirin will be added to placebo and clopidogrel until 90 days after stenting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Aspirin 100mg qd (21days)
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of occurrence of composite endpoint | *Composite endpoint: Neurologic deterioration†during admission (within 14 days) or recurrence of ischemic stroke‡ within 180 days after stroke †Neurologic deterioration: Increment of 2 or more in total NIHSS(National Institutes of Health Stroke Scale) score or one or more in the motor NIHSS score. ‡Recurrence of ischemic stroke: A newly developed neurological deficit corresponding to a new ischemic lesion confirmed by neuro-imaging. | during admission (within 14 days) and within 180 days after stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with good functional outcome (mRS(modified Rankin Scale) 0-2) | at 180 days | |
| mRS score collected at 180 days | at 180 days | |
| Proportion of participants with Neurologic Deterioration(ND) during admission |
| Measure | Description | Time Frame |
|---|---|---|
| Preplanned subgroup analysis | For the primary endpoint, analyses will be performed in the following subgroups: Proportion of occurrence of composite endpoint* in patients with
|
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bum Joon Kim, Professor | Contact | +82-2- 3010-3981 | bj.kim@amc.seoul.kr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | Songpa-gu | 05505 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Clopidogrel | Drug | Clopidogrel 75mg qd (180days)
|
|
| Cilostazol | Drug | Cilostazol SR 100mg x 2cap (180days)
|
|
| Placebo | Drug | Placebo x 2cap (180days)
|
|
| during admission(within 14days) |
| Proportion of participants with good functional outcome (mRS 0-2) | at 90 days |
| Proportion of participants with ischemic stroke recurrence | at 90 days |
| Proportion of participants with ischemic stroke recurrence | at 180 days |
| Proportion of participants with MI(Myocardial Infarction), ischemic stroke recurrence, haemorrhagic stroke and vascular death | within 180 days |
| Proportion of participants with haemorrhagic stroke | within 180 days |
| Proportion of participants with myocardial infarction | within 180 days |
| Proportion of participants with vascular death | within 180 days |
| mRS score collected at 90 days | at 90 days |
| during admission (within 14 days), within 180days |
| Time to recurrence of ischemic stroke | within 180days |
| Pusan National University Hospital | Recruiting | Busan | South Korea |
|
| Chungbuk National University Hospital | Recruiting | Cheongju-si | South Korea |
|
| Kyungpook National University Chilgok Hospital | Recruiting | Daegu | South Korea |
|
| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
|
| Eulji University Hospital | Recruiting | Daejeon | South Korea |
|
| Chonnam National University Hospital | Recruiting | Gwangju | South Korea |
|
| Seoul National University Bundang Hospital | Recruiting | Gyeonggi-do | 13620 | South Korea |
|
| Hallym University Medical Center | Recruiting | Gyeonggi-do | South Korea |
|
| Hanyang University Guri Hospital | Recruiting | Gyeonggi-do | South Korea |
|
| Korea University Ansan Hospital | Recruiting | Gyeonggi-do | South Korea |
|
| Gachon University Gil Medical Center | Recruiting | Incheon | 21565 | South Korea |
|
| Inha University Hospital | Recruiting | Incheon | South Korea |
|
| Jeju National University Hospital | Recruiting | Jeju City | South Korea |
|
| Jeonbuk National University Hospital | Recruiting | Jeonju | South Korea |
|
| Ewha Womans University Seoul Hospital | Recruiting | Seoul | South Korea |
|
| Hanyang University Seoul Hospital | Recruiting | Seoul | South Korea |
|
| Korea University Guro Hospital | Recruiting | Seoul | South Korea |
|
| Kyung Hee University Hospital at Gangdong | Recruiting | Seoul | South Korea |
|
| Kyung Hee University Hospital | Recruiting | Seoul | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| The Catholic University of Korea, Seoul St. Mary's Hospital | Recruiting | Seoul | South Korea |
|
| Yonsei University Health System, Gangnam Severance Hospital | Not yet recruiting | Seoul | South Korea |
|
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | South Korea |
|
| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D011804 | Quinolines |
Not provided
Not provided