Status:
COMPLETED
Cilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention of Cerebral Infarction.
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Cerebral Infarction
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 1992
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 1997
Estimated Enrollment :
1095 Patients enrolled
Trial Details
Trial ID
NCT00766545
Start Date
April 1 1992
End Date
March 1 1997
Last Update
March 1 2021
Active Locations (1)
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1
Kanto Area, Japan