Cerebral InfarctionPhase 4CHANGENCT06757764
The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis
A Phase 4 study testing Aspirin, Clopidogrel and Cilostazol in people with Cerebral Infarction and Stenosis Artery, run by Asan Medical Center at 24 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cerebral Infarction, Stenosis Artery
- What is being tested?
- Aspirin, Clopidogrel and Cilostazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,340 participants
- Where
- 24 sitesSouth Korea
- Study dates
- 10 Jul 2025to 31 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Large infarction unable to start antiplatelet treatment
- Combined with acute intracranial haemorrhage
- With initial haemorrhagic transformation
- Previous mRS higher than 2
- Indicated for anticoagulation
- Contraindication for aspirin, clopidogrel or cilostazol
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- Requirement of long term NSAID
- Pre-planned for surgery
- 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.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
South Korea24 sites, 24 recruiting
- Recruiting
Pusan National University Hospital
Busan
Hanjun Cho, +82-51-240-7000, chohj75@gmail.com
- Recruiting
Chungbuk National University Hospital
Cheongju-si
Hee-yoon Chae, MD, PhD, +82-1533-0075, chy4142@gmail.com
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu
Mi-Yeon Eun, MD, PhD, +82-1533-8888, eunmiyn@gmail.com
- Recruiting
Chungnam National University Hospital
Daejeon
Jong Wook Shin, MD, PhD, +82-1599-7123, jeonghs1028@gmail.com
- Recruiting
Eulji University Hospital
Daejeon
Jae Guk Kim, MD, PhD, +82-1899-0001, jgkim@eulji.ac.kr
- Recruiting
Chonnam National University Hospital
Gwangju
Kang-Ho Choi, MD, PhD, +82-1899-0000, ckhchoikang@hanmail.net
- Recruiting
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Beom Joon Kim, MD, PhD, +82-1588-3369, kim.bj.stroke@gmail.com
- Recruiting
Hallym University Medical Center
Gyeonggi-do
Minwoo Lee, MD, PhD, +82-1577-1801, minwoo.lee.md@gmail.com
- Recruiting
Hanyang University Guri Hospital
Gyeonggi-do
Hyuk Sung Kwon, MD, PhD, +82-1644-9118, hamohamo1318@gmail.com
- Recruiting
Korea University Ansan Hospital
Gyeonggi-do
Jin-Man Jung, MD, PhD, +82-31-412-5114, sodium75@hanmail.net
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
SangHee Ha, MD, PhD, +82-1577-2299, shha31@naver.com
- Recruiting
Inha University Hospital
Incheon
Cindy W Yoon, MD, PhD, +82-1600-8114, cindywyoon1981@gmail.com
- Recruiting
Jeju National University Hospital
Jeju City
Joong Goo Kim, MD, PhD, +82-64-717-1114, lilis1118@naver.com
- Recruiting
Jeonbuk National University Hospital
Jeonju
Hyun Goo Kang, MD, PhD, +82-1577-7877, hgkang@jbnu.ac.kr
- Recruiting
Asan Medical Center
Seoul, Songpa-gu, 05505
Bum Joon Kim, MD, PhD, +82-2-3010-3981, medicj80@hanmail.net
- Recruiting
Ewha Womans University Seoul Hospital
Seoul
Tae-Jin Song, MD, PhD, +82-1522-7000, knstar@hanmail.net
- Recruiting
Hanyang University Seoul Hospital
Seoul
Youngseo Kim, MD, PhD, +82-2-2290-8114, aescula@hanmail.net
- Recruiting
Korea University Guro Hospital
Seoul
Chi Kyung Kim, MD, PhD, +82-1577-9966, ckkim7@gmail.com
- Recruiting
Kyung Hee University Hospital at Gangdong
Seoul
Kyung Chul Noh, MD, PhD, +82-1577-5800, kyungchulnoh85@gmail.com
- Recruiting
Kyung Hee University Hospital
Seoul
Hogeol Woo, MD, PhD, +82-2-958-8114, nr85plasma@gmail.com
- Recruiting
Samsung Medical Center
Seoul
Woo Keun Seo, MD, PhD, +82-1599-3114, mcastenosis@gmail.com
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Minhwan Lee, MD, PhD, +82-1588-1511, prelee01@naver.com
- Not yet recruiting
Yonsei University Health System, Gangnam Severance Hospital
Seoul
Yo Han Jung, MD, PhD, +82-1599-6114, yhjung@yuhs.ac
- Recruiting
Pusan National University Yangsan Hospital
Yangsan
Sungho Ahn, MD, PhD, +82-1577-7512, caesar-ahn@hanmail.net
About this study
Official title: The Effect and Safety of Therapy Adding Cilostazol in Acute Ischemic Stroke Due to Large Artery Atherosclerosis: CHANGE Trial
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.
- Conditions
- Cerebral Infarction, Stenosis Artery
- Being tested
- Aspirin, Clopidogrel, Cilostazol, Placebo
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
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)
ClopidogrelDrug
Clopidogrel 75mg qd (180days)
- Route: per oral. IMP can be taken with or without food.
- Frequency: once daily (qd)
CilostazolDrug
Cilostazol SR 100mg x 2cap (180days)
- Route: per oral. IMP can be taken with or without food.
- Frequency: once daily (qd)
PlaceboDrug
Placebo x 2cap (180days)
- Route: per oral. IMP can be taken with or without food.
- Frequency: once daily (qd)
| Study group | Role | What they receive |
|---|---|---|
| CA group | Experimental | 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. Receives: Drug: Aspirin; Drug: Clopidogrel; Drug: Cilostazol |
| PA group | Placebo comparator | 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. Receives: Drug: Aspirin; Drug: Clopidogrel; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during admission (within 14 days) and within 180 days after stroke
Secondary outcomes (11)
Proportion of participants with good functional outcome (mRS(modified Rankin Scale) 0-2)
Measured: at 180 days
mRS score collected at 180 days
Measured: at 180 days
Proportion of participants with Neurologic Deterioration(ND) during admission
Measured: during admission(within 14days)
Proportion of participants with good functional outcome (mRS 0-2)
Measured: at 90 days
Proportion of participants with ischemic stroke recurrence
Measured: at 90 days
Proportion of participants with ischemic stroke recurrence
Measured: at 180 days
Proportion of participants with MI(Myocardial Infarction), ischemic stroke recurrence, haemorrhagic stroke and vascular death
Measured: within 180 days
Proportion of participants with haemorrhagic stroke
Measured: within 180 days
Proportion of participants with myocardial infarction
Measured: within 180 days
Proportion of participants with vascular death
Measured: within 180 days
mRS score collected at 90 days
Measured: at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start10 Jul 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2,340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Bum Joon Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757764
- Sponsor's protocol ID
- CHANGE
- Acronym
- CHANGE
- Status last verified
- Mar 2026
- First submitted
- 26 Dec 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Safety of Therapy Adding Cilostazol in Acute Ischemic Stroke Due to Large Artery Atherosclerosis: CHANGE Trial
- ClinicalTrials.gov ID
- NCT06757764
- Acronym / sponsor ID
- CHANGE / CHANGE
- Conditions
- Cerebral Infarction, Stenosis Artery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,340 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CA group | Experimental | Drug: Aspirin, Drug: Clopidogrel, Drug: CilostazolAspirin 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. |
| PA group | Placebo comparator | Drug: Aspirin, Drug: Clopidogrel, Drug: PlaceboAspirin 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Large infarction unable to start antiplatelet treatment
- Combined with acute intracranial haemorrhage
- With initial haemorrhagic transformation
- Previous mRS higher than 2
- Indicated for anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAspirin 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) | Drug | CA group, PA group |
| ClopidogrelClopidogrel 75mg qd (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd) | Drug | CA group, PA group |
| CilostazolCilostazol SR 100mg x 2cap (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd) | Drug | CA group |
| PlaceboPlacebo x 2cap (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd) | Drug | PA group |
Primary outcome
Proportion of occurrence of composite endpoint
Time frame: during admission (within 14 days) and within 180 days after stroke
*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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin, Clopidogrel and Cilostazol in people with Cerebral Infarction and Stenosis Artery, run by Asan Medical Center at 24 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bum Joon Kim, Professor (+82-2- 3010-3981, bj.kim@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of occurrence of composite endpoint (time frame: during admission (within 14 days) and within 180 days after stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.