Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
The purpose of this study is to investigate the efficacy of cilostazol in preventing
 recurrence of cerebral infarction and the safety of long-term administration of the drug (100
 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral
 embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg,
 once daily).
Inclusion Criteria:

 1. Patients with stable medical conditions for 182 days (26 weeks) after occurrence of
 cerebral infarction

 2. Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI

 3. Patients aged 20 to 80 years (inclusive) at time of consent

 4. Patients with none of the following cardiac diseases that may be associated with
 cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis,
 myocardial infarction within 6 weeks after occurrence, ventricular aneurysm,
 endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in
 whom no other cause was identified), atrial fibrillation, sick sinus syndrome,
 idiopathic cardiomyopathy, and patent foramen ovale

 5. Patients without asymptomatic cerebral infarction

 6. Patients who have neither undergone nor are scheduled to undergo percutaneous
 transluminal angioplasty or revascularization for the treatment of cerebral infarction

 7. Patients without severe disturbances/impairments following occurrence of cerebral

 Exclusion Criteria:

 1. Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility,
 intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary
 tract, hemoptysis, and hemorrhage in the vitreous body)

 2. Pregnant, possibly pregnant, or nursing women

 3. Patients with ischemic heart failure

 4. Patients with peptic ulcer

 5. Patients with severer blood disorders

 6. Patients with severe hepatic or renal

 7. Patients with malignant neoplasm or patients who have received any therapy for
 malignant neoplasm within 5 years prior to entering the study

 8. Patients with a history of hypersensitivity to salicylic acid formulations or
 ingredients of cilostazol tablets

 9. Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory
 analgesic agents) or a history of aspirin asthma

 10. Patients who are being treated with ticlopidine hydrochloride

 11. Patients who are participating in another study for an investigational drug

 12. Patients who are otherwise judged inappropriate for inclusion in the study by the
 investigators