Cilostazol Stroke Prevention Study : A Placebo-Controlled Double-Blind Trial for Secondary Prevention of Cerebral Infarction.

Official Title: “Cilostazol Stroke Prevention Study : A Placebo-Controlled Double-Blind Trial for Secondary Prevention of Cerebral Infarction.”

The multi-center, double-blind, placebo-controlled, randomized, group-comparison study was designated to assess the long-term safety and efficacy of the antiplatelet drug cilostazol in preventing the recurrence of cerebral infarction in patients who had suffered a cerebral infarction 1 to 6 months prior to entering the trial.

Intervention(s) in this Clinical Trial

• Drug: cilostazol
  • oral tablet 100 mg, twice daily, over 1 year
• Drug: placebo of cilostazol
  • oral tablet, 0 mg twice daily, over 1 year

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: cilostazol
  • cilostazol oral tablet 100 mg, twice daily
• Placebo Comparator: placebo
  • placebo of cilostazol, twice daily

Primary Measures

• Recurrence of cerebral infarction
  • Time Frame: any time
    Safety Issue?: Yes

Secondary Measures

• Cerebral infarction or myocardial infarction, Cerebral infarction, intracranial hemorrhage, or TIA, Cerebral infarction, intracranial hemorrhage, myocardial infarction, or vascular death, All vascular events, vascular death, and Death from any cause
  • Time Frame: any time
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Prior cerebral infarction Onset at 1 to 6 months before randomization
• 2. CT or MRI detection of responsible site
• 3. Without serious complications (malignant tumor, liver cirrhosis, renal failure, or heart failure)

Exclusion Criteria:

• 1. History of intracranial hemorrhage
• 2. Possibility of cardiogenic cerebral embolism in the past or future All patients with any of the following complications were excluded: mitral valve stenosis, prosthetic valve, endocarditis, myocardial infarction within 6 weeks after onset, ventricular aneurysm, intraventricular or intraatrial blood clots, mitral valve prolapsed (age under 45 years old, lacking other causes for cerebral embolism induction), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy
• 3. Severe cerebral deficits rendering the patient bed-ridden, totally dependent, or demented
• 4. Contraindications to the study drug Hemostatic disorders or systemic bleeding
• Pregnant or possibly pregnant women, or nursing mothers
• 5. Requirement for nonstudy antiplatelet drugs, anticoagulant drugs, or fibrinolytic drugs for another disease

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00766545

Study ID Number: 021-91-001

ClinicalTrials.gov Identifier: NCT00766545

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