Cerebral Infarction
Conditions
Keywords
cilostazol, aspirin, cerebral infarction
Brief summary
The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.
Detailed description
Stroke is a leading cause of death and elderly disability in developed countries. However, treatment of acute stroke is limited except thrombolytic therapy in hyperacute stroke within several hours. Currently, aspirin is widely used in spite of its small benefit compared to bleeding complications. Cilostazol will be compared to aspirin in acute stroke patients in terms of functional outcome at 3 months, efficacy to prevent stroke recurrence, and safety for bleeding complications.
Interventions
DRUGCilostazol
DRUGAspirin
Sponsors
Seoul National University Boramae Hospital
Korea Otsuka International Asia Arab Co., Ltd.
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients who receive explanation on this study and give informed consent * Patients aged 30 to 85 years * Baseline NIHSS less than 15 * Onset of symptoms within 48 hours of the start of investigational product * Full functional independence prior to the present stroke indicated by an mRS score of 0, 1, 2
Exclusion criteria
* Evidence from CT or MRI scan of an acute intracranial hemorrhage, a tumor, encephalitis or any diagnosis other than acute ischemic stroke likely to cause the present symptoms. * Previous regular use of an antiplatelet agent or warfarin * Patients with known cardiac disease likely to cause cardiogenic embolism or congestive heart failure * Evidence from CT or MRI scan of midline shift when visiting hospital * Uncontrolled hypertension (SBP\>220 mmHg or DBP\>120 mmHg) * Hypotension (\<90/60 mmHg) * Patients with known bleeding diathesis or coagulation disorder * Patients with liver disease (ALT\>100 or AST\>100), or renal disease (creatinine\>2.0 mg/dl) * Known severe anaemia (hemoglobin\<8.0 mg/dl), or thrombocytopenia (platelet\<100,000/mm3) * Scheduled for endarterectomy within 3 months * Severe co-morbidity likely to limit patient's life expectancy to less than 6 months * Patients with alcohol or illegal drug abuse or dependency * Pregnant or lactating patients. When administrating to females, it should be confirmed that the patients is in the menopause (by evaluation of investigators) or permanently infertile (hysterectomy or surgical operation like bilateral tubal ligation, bilateral oophorectomy, etc). If a patient is likely to be pregnant, the patient should not be pregnant before randomization. And, the patient should use reliable contraception between at least 3 weeks before randomization to 7 days after the final administration of study drug. * Patients treated by thrombolytic agents like tPA after onset of stroke
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the frequency of mRS 0, 1, 2 at 90 days | at 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of Barthel index 95-100 at 90 days | — |
| Frequency of mRS 0,1 & Barthel index 95-100 at 90 days | — |
| Frequency of NIHSS 0-1 at 90 days | — |
| Frequency of mRS 0,1 at 90 days | at 90 days |
| Bleeding disorders (life-threatening bleeding; major bleeding; minor Bleeding) | — |
| Overall cardiovascular events (Ischemic heart disease requiring rehospitalization) | — |
| Frequency of progression of neurological deficit at 7 days (increment of NIHSS 2 points or a point on the item of upper or lower extremity weakness) | — |
Countries
South Korea
Outcome results
None listed