Clinical trial NCT06757764: The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis
Official title: The Effect and Safety of Therapy Adding Cilostazol in Acute Ischemic Stroke Due to Large Artery Atherosclerosis: CHANGE Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Cerebral Infarction
Stenosis Artery
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Otsuka Pharmaceutical Co., Ltd.
First posted: 2025-01-03
Enrollment: 2340
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

1. Age of 20 years or older
2. 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.
3. Able to start IMP within 72h from stroke onset
4. Acquisition of written informed consent prior to study entry

Exclusion Criteria:

1. Large infarction unable to start antiplatelet treatment
2. Combined with acute intracranial haemorrhage
3. With initial haemorrhagic transformation
4. Previous mRS higher than 2
5. Indicated for anticoagulation
6. Contraindication for aspirin, clopidogrel or cilostazol
7. Requirement of long term NSAID
8. Pre-planned for surgery
9. Unable to withdraw consent
10. Unavailable to participate based on judgement of the investigator
11. 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.

Primary outcomes:
measure: Proportion of occurrence of composite endpoint
timeFrame: during admission (within 14 days) and within 180 days after stroke
Secondary outcomes:
measure: Proportion of participants with good functional outcome (mRS(modified Rankin Scale) 0-2)
timeFrame: at 180 days
measure: mRS score collected at 180 days
timeFrame: at 180 days
measure: Proportion of participants with Neurologic Deterioration(ND) during admission
timeFrame: during admission(within 14days)
measure: Proportion of participants with good functional outcome (mRS 0-2)
timeFrame: at 90 days
measure: Proportion of participants with ischemic stroke recurrence
timeFrame: at 90 days
measure: Proportion of participants with ischemic stroke recurrence
timeFrame: at 180 days
measure: Proportion of participants with MI(Myocardial Infarction), ischemic stroke recurrence, haemorrhagic stroke and vascular death
timeFrame: within 180 days
measure: Proportion of participants with haemorrhagic stroke
timeFrame: within 180 days
measure: Proportion of participants with myocardial infarction
timeFrame: within 180 days
measure: Proportion of participants with vascular death
timeFrame: within 180 days
measure: mRS score collected at 90 days
timeFrame: at 90 days
Other outcomes:
measure: Preplanned subgroup analysis
timeFrame: during admission (within 14 days), within 180days
measure: Time to recurrence of ischemic stroke
timeFrame: within 180days
Locations:
Study officials:
References: