RecruitingPhase 4NCT06757764

The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis

The Effect and Safety of Therapy Adding Cilostazol in Acute Ischemic Stroke Due to Large Artery Atherosclerosis: CHANGE Trial


Sponsor

Asan Medical Center

Enrollment

2,340 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Aspirin, a drug called Cilostazol, and others for people with cerebral infarction and stenosis artery. The study is currently recruiting participants at 24 locations. People eligible for this study include aged 20 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAspirin

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)

DRUGClopidogrel

Clopidogrel 75mg qd (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)

DRUGCilostazol

Cilostazol SR 100mg x 2cap (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT06757764


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