Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cerebral Infarction |
Drug: Cilostazol 200mg/day Oral Drug: Aspirin 100mg/day Oral |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Cilostazol Stroke Prevention Study-a Randomized, Double Blind, Double Dummy, Parallel Comparative, Multicenter Clinical Trial |
- Recurrence of stroke(cerebral infarction/haemorrhage/subarachnoid haemorrhage)
- 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
| Estimated Enrollment: | 720 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | January 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
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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. -
-
Contacts and Locations| 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 | |
| China | |
| Renmin Hospital, Peking University | |
| Beijing, China | |
| General Hospital of Beijing Military Area of PLA | |
| Beijing, China | |
| 1st affiliated hospital, Peking University | |
| Beijing, China | |
| 3rd affiliated 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 | |
| Principal Investigator: | Yi N Huang, Professor | Peking University First Hospital |
More Information
No publications provided by Otsuka Beijing Research Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00202020 History of Changes |
| Other Study ID Numbers: | OBRI0001 |
| Study First Received: | September 12, 2005 |
| Last Updated: | March 15, 2006 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Otsuka Beijing Research Institute:
|
Cerebral infarction Prevention Cilostazol |
Aspirin Stroke Clinical trial |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Infarction Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Ischemia Pathologic Processes Necrosis Aspirin |
Cilostazol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013