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The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis
Sponsor: Asan Medical Center
Summary
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.
Official title: The Effect and Safety of Therapy Adding Cilostazol in Acute Ischemic Stroke Due to Large Artery Atherosclerosis: CHANGE Trial
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2340
Start Date
2025-07-10
Completion Date
2028-03-31
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Aspirin
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
Clopidogrel 75mg qd (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)
Cilostazol
Cilostazol SR 100mg x 2cap (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)
Placebo
Placebo x 2cap (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)
Locations (24)
Asan Medical Center
Seoul, Songpa-gu, South Korea
Pusan National University Hospital
Busan, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Eulji University Hospital
Daejeon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Hallym University Medical Center
Gyeonggi-do, South Korea
Hanyang University Guri Hospital
Gyeonggi-do, South Korea
Korea University Ansan Hospital
Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Jeju National University Hospital
Jeju City, South Korea
Jeonbuk National University Hospital
Jeonju, South Korea
Ewha Womans University Seoul Hospital
Seoul, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
Kyung Hee University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Yonsei University Health System, Gangnam Severance Hospital
Seoul, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea