The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.

Condition	Intervention	Phase
Cerebral Infarction	Drug: Cilostazol versus Aspirin	Phase IV

Further study details as provided by Seoul National University Hospital:

Primary Outcomes: Comparison of the frequency of mRS 0, 1, 2 at 90 days
Secondary Outcomes: Frequency of mRS 0,1 at 90 days; Frequency of Bathel index 95-100 at 90 days; Frequency of mRS 0,1 & Bathel index 95-100 at 90 days; Frequency of NIHSS 0-1 at 90 days; 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); Bleeding disorders (life-threatening bleeding; major bleeding; minor Bleeding); Overall cardiovascular events (Ischemic heart disease requiring rehospitalization)
Expected Total Enrollment:  442

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 is a selective inhibitior of phosphodiesterase III, which has antiplatelet and vasodilating effects. It has been known to have less bleeding tendency compared with aspirin or clopidogrel in spite of its antiaggregating effect. Recent studies show beneficial effects of cilostazol in animal model or observatoinal studies in acute stroke. Based on these clinical and experimental evidences, cilostazol can be a new candidate to substitute aspirin in acute stroke. So, this study was planned to confirm the efficacy and safety of cilostazol compared to aspirin. 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.

Ages Eligible for Study:  30 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients who receive explanation on this study and give informed consent
• Patients aged 30 to 85 years
• Baseline NIHSS >0, and ≤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 hospita
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00272129

Yong-Seok Lee, MD, PhD      +8228402492    lys@brm.co.kr

Study chairs or principal investigators

Yong-Seok Lee, MD., PhD.,  Principal Investigator,  Department of Neurology, Seoul National University Boramae Hospita, College of Medicine, Seoul National University   

Study ID Numbers:  KOP-PLT-0501
Last Updated:  January 3, 2006
Record first received:  January 3, 2006
ClinicalTrials.gov Identifier:  NCT00272129
Health Authority: Korea: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10