Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
Condition: Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Intervention: Cilostazol; Aspirin
Intervention description: oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years; oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years
Intervention MeSH terms: Aspirin; Cilostazol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2800.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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