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

Study Overview
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Brief Summary
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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.

Official Title
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Cilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention of Cerebral Infarction.

Conditions
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Cerebral Infarction

Intervention / Treatment
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* Drug: cilostazol
* Drug: placebo of cilostazol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior cerebral infarction Onset at 1 to 6 months before randomization CT or MRI detection of responsible site Without serious complications (malignant tumor, liver cirrhosis, renal failure, or heart failure) Exclusion Criteria: History of intracranial hemorrhage 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 Severe cerebral deficits rendering the patient bed-ridden, totally dependent, or demented Contraindications to the study drug Hemostatic disorders or systemic bleeding Pregnant or possibly pregnant women, or nursing mothers Requirement for nonstudy antiplatelet drugs, anticoagulant drugs, or fibrinolytic drugs for another disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cilostazol<br>cilostazol oral tablet 100 mg, twice daily | Drug: cilostazol<br>* oral tablet 100 mg, twice daily, over 1 year<br>|
| Placebo Comparator: placebo<br>placebo of cilostazol, twice daily | Drug: placebo of cilostazol<br>* oral tablet, 0 mg twice daily, over 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of cerebral infarction |  | any time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | any time |