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

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 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.

Condition or disease Intervention/treatment Phase
Cerebral Infarction Drug: Cilostazol 200mg/day Oral Drug: Aspirin 100mg/day Oral Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Cilostazol Stroke Prevention Study-a Randomized, Double Blind, Double Dummy, Parallel Comparative, Multicenter Clinical Trial
Study Start Date : May 2004
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol

Primary Outcome Measures :
  1. Recurrence of stroke(cerebral infarction/haemorrhage/subarachnoid haemorrhage)

Secondary Outcome Measures :
  1. Recurrence of cerebral infarction detected in MRI
  2. Death due to cerebral vascular events
  3. Myocardial infarction
  4. Vascular events(acute artery thrombosis/embolism, pneumonia embolism, venous thrombosis, angina pectoris)
  5. TIA
  6. Death

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00202020

China, Guangdong
1st affiliated hospital, Guangzhou Zhongshan University
Guangzhou, Guangdong, China
2nd affiliated hospital, Guangzhou medical college
Guangzhou, Guangdong, China
China, Jilin
1st affiliated Jilin University
Changchun, Jilin, China
China, Shanxi
1st affiliated hospital, Xi'an Jiatong University
Xi'an, Shanxi, China
China, Zhejiang
2nd affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China
1st affiliated hospital, Peking University
Beijing, China
3rd affiliated hospital, Peking University
Beijing, China
General Hospital of Beijing Military Area of PLA
Beijing, China
Renmin Hospital, Peking University
Beijing, China
Huashan Hospital Shanghai Fudan University
Shanghai, China
Renji Hospital, Shanghai 2nd medical university
Shanghai, China
General Hospital, Tianjin Medical University
Tianjin, China
Sponsors and Collaborators
Otsuka Beijing Research Institute
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Principal Investigator: Yi N Huang, Professor Peking University First Hospital

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00202020     History of Changes
Other Study ID Numbers: OBRI0001
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 16, 2006
Last Verified: March 2006

Keywords provided by Otsuka Beijing Research Institute:
Cerebral infarction
Clinical trial

Additional relevant MeSH terms:
Cerebral Infarction
Pathologic Processes
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors