Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)

Official Title: “Post-marketing Study of Cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison With Aspirin”

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).

Intervention(s) in this Clinical Trial

• Drug: Cilostazol
  • oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years
• Drug: Aspirin
  • oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • cilostazol
• Active Comparator: 2
  • Aspirin

Primary Measures

• Numbers of Patients With First Occurence of Stroke
  • Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months])
    Safety Issue?: No

Secondary Measures

• Number of Patients With First Recurrence of Cerebral Infarction
  • Time Frame: From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
    Safety Issue?: No
• Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease
  • Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
    Safety Issue?: No
• Number of Deaths From Any Cause
  • Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
    Safety Issue?: No
• Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events
  • Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Otsuka Pharmaceutical Co., Ltd. Industry

Overall Clinical Trial Officials and Contacts

Masahiko Abe Study Director Division of New Product Evaluation and Development  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00234065

Study ID Number: C02100-002

ClinicalTrials.gov Identifier: NCT00234065

Health Authority: Japan: Ministry of Health, Labor and Welfare