Status:
COMPLETED
Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke
Lead Sponsor:
Otsuka Beijing Research Institute
Collaborating Sponsors:
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Conditions:
Cerebral Infarction
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The study design is subject to relevant SFDA regulations about clinical trials. This indication was approved in Japan in 2003. From the end of May 2004 to the end of Dec. 2004, 720 patients with prev...
Eligibility Criteria
Inclusion
- 1\. Patients who had cerebral infarction within 6 months and 1 month before entry 2. Within a few days of the onset of cerebral infarction onset, CT or MRI showed evidence of infarction that could be responsible for this stroke onset 3. A modified ranking scale of less than 4 4. Aged 18\~75 5. Consent of the patients or their legal guardians
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Exclusion
- 1\. History of intracranial hemorrhage 2. Stroke secondary to cardiogenic embolism 3. Serious damage of motorial function, dementia 4. Serious complications or co morbidity(uncontrolled accelerated type of hypertension, BP\>180/120mmHg, diabetic acidosis, heart failure, renal failure, hepatocirrhosis, malignant tumor) 5. Contraindication of Cilostazol and Aspirin 6. Patients who need co medication of other antiplatelet agents, anticoagulants or fibrinolytic drugs 7. Active peptic ulcer 8. Pregnancy or breast feeding 9. Judged to be inappropriate to enter the study by investigators. -
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Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT00202020
Start Date
May 1 2004
End Date
January 1 2006
Last Update
March 16 2006
Active Locations (12)
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1
1st affiliated hospital, Guangzhou Zhongshan University
Guangzhou, Guangdong, China
2
2nd affiliated hospital, Guangzhou medical college
Guangzhou, Guangdong, China
3
1st affiliated Jilin University
Changchun, Jilin, China
4
1st affiliated hospital, Xi'an Jiatong University
Xi’an, Shanxi, China