Cerebral Infarction, Stenosis Artery
Conditions
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.
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)
Sponsors
Asan Medical Center
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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 angiography or CT angiography. 3. Informed consent obtained 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of occurrence of composite endpoint | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with good functional outcome (mRS(modified Rankin Scale) 0-2) | at 180 days |
| mRS score collected at 180 days | at 180 days |
| Proportion of participants with Neurologic Deterioration(ND) during admission | during admission(within 14days) |
| Proportion of participants with good functional outcome (mRS 0-2) | at 90 days |
| Proportion of participants with ischemic stroke recurrence | at 90 days |
| Proportion of participants with MI(Myocardial Infarction), ischemic stroke recurrence, haemorrhagic stroke and vascular death | within 180 days |
| Proportion of participants with haemorrhagic stroke | within 180 days |
| Proportion of participants with myocardial infarction | within 180 days |
| Proportion of participants with vascular death | within 180 days |
| mRS score collected at 90 days | at 90 days |
Countries
South Korea
Contacts
CONTACTBum Joon Kim, Professor
Outcome results
None listed