Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00202020
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 16, 2006
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Beijing Research Institute

September 12, 2005
September 20, 2005
March 16, 2006
May 2004
Not Provided
Recurrence of stroke(cerebral infarction/haemorrhage/subarachnoid haemorrhage)
Same as current
Complete list of historical versions of study NCT00202020 on Archive Site
  • Recurrence of cerebral infarction detected in MRI
  • Death due to cerebral vascular events
  • Myocardial infarction
  • Vascular events(acute artery thrombosis/embolism, pneumonia embolism, venous thrombosis, angina pectoris)
  • TIA
  • Death
Same as current
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Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke
Cilostazol Stroke Prevention Study-a Randomized, Double Blind, Double Dummy, Parallel Comparative, Multicenter Clinical Trial

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 previous cerebral infarction(see the inclusion criteria) were enrolled in to the study and received one of the two treatment regimens, Cilostazol or Aspirin, the ratio of patient number of each group is 1:1. For each patient, the chance of entering either of these two groups is the same. The treatment will continue till the end of 2005. During the treatment period, patients will be observed concerning some certain events, mainly reoccurrence of stroke. If the patient experiences reoccurrence of stroke, or other event that the doctors think it is not appropriate to continue the study medication, this patient would stop the treatment. Patients were also required to take MRI head scan before entering the study and on completion of the treatment.

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Cerebral Infarction
  • Drug: Cilostazol 200mg/day Oral
  • Drug: Aspirin 100mg/day Oral
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2006
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Inclusion Criteria:

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

Exclusion Criteria:

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. -

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Otsuka Beijing Research Institute
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Principal Investigator: Yi N Huang, Professor Peking University First Hospital
Otsuka Beijing Research Institute
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP