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  Drug: Aspirin	Phase IV

Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

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 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 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 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 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00272454

BoYoun Seo      +82-2-3467-6872    byseo@otsuka.co.kr

Korea, Republic of
      Seoul National University Boramae Hospital, Seoul,  156-707,  Korea, Republic of

Study chairs or principal investigators

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

Study ID Numbers:  KOP-PLT-0501
Last Updated:  January 5, 2006
Record first received:  January 3, 2006
ClinicalTrials.gov Identifier:  NCT00272454
Health Authority: Korea: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10