The Effect and Safety of Therapy Adding Cilostazol in Acute Ischemic Stroke Due to Large Artery Atherosclerosis: CHANGE Trial
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:
• Age of 20 years or older
• Acute ischemic stroke due to large artery atherosclerosis (both including Intra and extracranial atherosclerosis) which may be defined by a ischemic lesion confirmed at diffusion-weighted image and a corresponding significant stenosis (more than 50% of diameter reduction) proximal to the ischemic lesion confirmed by MR or CT angiography.
• Able to start IMP within 72h from stroke onset
• Acquisition of written informed consent prior to study entry
Locations
Other Locations
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Chungbuk National University Hospital
NOT_YET_RECRUITING
Cheongju-si
Kyungpook National University Chilgok Hospital
NOT_YET_RECRUITING
Daegu
Chungnam National University Hospital
NOT_YET_RECRUITING
Daejeon
Eulji University Hospital
NOT_YET_RECRUITING
Daejeon
Chonnam National University Hospital
RECRUITING
Gwangju
Hallym University Medical Center
NOT_YET_RECRUITING
Gyeonggi-do
Hanyang University Guri Hospital
NOT_YET_RECRUITING
Gyeonggi-do
Korea University Ansan Hospital
NOT_YET_RECRUITING
Gyeonggi-do
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Gyeonggi-do
Gachon University Gil Medical Center
RECRUITING
Incheon
Inha University Hospital
NOT_YET_RECRUITING
Incheon
Jeju National University Hospital
NOT_YET_RECRUITING
Jeju City
Jeonbuk National University Hospital
NOT_YET_RECRUITING
Jeonju
Asan Medical Center
RECRUITING
Seoul
Ewha Womans University Seoul Hospital
NOT_YET_RECRUITING
Seoul
Hanyang University Seoul Hospital
NOT_YET_RECRUITING
Seoul
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
Kyung Hee University Hospital
NOT_YET_RECRUITING
Seoul
Kyung Hee University Hospital at Gangdong
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
Yonsei University Health System, Gangnam Severance Hospital
NOT_YET_RECRUITING
Seoul
Pusan National University Yangsan Hospital
NOT_YET_RECRUITING
Yangsan
Contact Information
Primary
Bum Joon Kim, Professor
bj.kim@amc.seoul.kr
+82-2- 3010-3981
Time Frame
Start Date:2025-07-10
Estimated Completion Date:2028-03-31
Participants
Target number of participants:2340
Treatments
Experimental: CA group
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.
Placebo_comparator: PA group
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.