Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

This study has been completed.
Sponsor:
Collaborator:
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier:
NCT00202020
First received: September 12, 2005
Last updated: March 15, 2006
Last verified: March 2006
  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

Resource links provided by NLM:


Further study details as provided by Otsuka Beijing Research Institute:

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

Secondary Outcome Measures:
  • 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
Criteria

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. -

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202020

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
3rd affiliated hospital, Peking University
Beijing, China
General Hospital of Beijing Military Area of PLA
Beijing, China
1st 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
Sponsors and Collaborators
Otsuka Beijing Research Institute
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Investigators
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
Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Cilostazol
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014