NCT06757764RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2340 (estimated)
- First submitted
- 26 Dec 2024
- Start date
- 10 Jul 2025
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Asan Medical Center
- Diseases
- Stroke
- NCT number
- NCT06757764
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 2340
- From 10 Jul 2025 to the primary completion date, 31 Mar 2028
- 24 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous mRS higher than 2
- Pre-planned for surgery
Other illness
- Combined with acute intracranial haemorrhage
Other
- Large infarction unable to start antiplatelet treatment
- With initial haemorrhagic transformation
- Indicated for anticoagulation
- Contraindication for aspirin, clopidogrel or cilostazol
- Requirement of long term NSAID
- Unable to withdraw consent
- Unavailable to participate based on judgement of the investigator
- Participants of reproductive potential (PORP)/ Participants of childbearing potential (POCBP) who do not agree to practice methods of birth control or remain fully abstinent from sexual activity with the potential for conception.
Who the study is looking for
- 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 angiography or CT angiography.
- Informed consent obtained within 72h from stroke onset
- Acquisition of written informed consent prior to study entry
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Recruiting |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Recruiting |
| Eulji University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Recruiting |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Recruiting |
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Recruiting |
| Hanyang University Guri Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Recruiting |
| Hallym University Medical Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Recruiting |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Inha University Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Jeju National University Hospital Coordinator of this site? Confirm its status | Jeju City | South Korea | Recruiting |
| jeonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Recruiting |
| Yonsei University Health System - Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Kyung Hee University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ewha Womans University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Hanyang University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Kyung Hee University Hospital at Gangdong Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.