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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,340
Aspirin 100mg qd (21days) * In case of stenting, aspirin will be added to cilostazol and clopidogrel until 90 days after stenting. * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)
Clopidogrel 75mg qd (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)
Cilostazol SR 100mg x 2cap (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)
Placebo x 2cap (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)
Asan Medical Center
Seoul, Songpa-gu, South Korea
RECRUITINGPusan National University Hospital
Busan, South Korea
RECRUITINGChungbuk National University Hospital
Cheongju-si, South Korea
RECRUITINGKyungpook National University Chilgok Hospital
Daegu, South Korea
RECRUITINGChungnam National University Hospital
Daejeon, South Korea
RECRUITINGEulji University Hospital
Daejeon, South Korea
RECRUITINGChonnam National University Hospital
Gwangju, South Korea
RECRUITINGSeoul National University Bundang Hospital
Gyeonggi-do, South Korea
RECRUITINGHallym University Medical Center
Gyeonggi-do, South Korea
RECRUITINGHanyang University Guri Hospital
Gyeonggi-do, South Korea
RECRUITING...and 14 more locations
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.
Time frame: during admission (within 14 days) and within 180 days after stroke
Proportion of participants with good functional outcome (mRS(modified Rankin Scale) 0-2)
Time frame: at 180 days
mRS score collected at 180 days
Time frame: at 180 days
Proportion of participants with Neurologic Deterioration(ND) during admission
Time frame: during admission(within 14days)
Proportion of participants with good functional outcome (mRS 0-2)
Time frame: at 90 days
Proportion of participants with ischemic stroke recurrence
Time frame: at 90 days
Proportion of participants with ischemic stroke recurrence
Time frame: at 180 days
Proportion of participants with MI(Myocardial Infarction), ischemic stroke recurrence, haemorrhagic stroke and vascular death
Time frame: within 180 days
Proportion of participants with haemorrhagic stroke
Time frame: within 180 days
Proportion of participants with myocardial infarction
Time frame: within 180 days
Proportion of participants with vascular death
Time frame: within 180 days
mRS score collected at 90 days
Time frame: at 90 days
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