Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke - Full Text View

Sponsors and Collaborators:	Otsuka Beijing Research Institute Zhejiang Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier:	NCT00202020

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Cilostazol Stroke Prevention Study-a Randomized, Double Blind, Double Dummy, Parallel Comparative, Multicenter Clinical Trial

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Cilostazol

U.S. FDA Resources

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:

History of intracranial hemorrhage
Stroke secondary to cardiogenic embolism
Serious damage of motorial function, dementia
Serious complications or co morbidity(uncontrolled accelerated type of hypertension, BP>180/120mmHg, diabetic acidosis, heart failure, renal failure, hepatocirrhosis, malignant tumor)
Contraindication of Cilostazol and Aspirin
Patients who need co medication of other antiplatelet agents, anticoagulants or fibrinolytic drugs
Active peptic ulcer
Pregnancy or breast feeding
Judged to be inappropriate to enter the study by investigators. -

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Contacts and Locations

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

Locations

China
1st affiliated hospital, Peking University
Beijing, China
Huashan Hospital Shanghai Fudan University
Shanghai, China
General Hospital of Beijing Military Area of PLA
Beijing, China
Renmin Hospital, Peking University
Beijing, China
Renji Hospital, Shanghai 2nd medical university
Shanghai, China
General Hospital, Tianjin Medical University
Tianjin, China
3rd affiliated hospital, Peking University
Beijing, China
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

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

Study ID Numbers:	OBRI0001
Study First Received:	September 12, 2005
Last Updated:	March 15, 2006
ClinicalTrials.gov Identifier:	NCT00202020 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Otsuka Beijing Research Institute:

Cerebral infarction
Prevention
Cilostazol

Aspirin
Stroke
Clinical trial

Study placed in the following topic categories:

Anti-Inflammatory Agents
Vasodilator Agents
Cerebral Infarction
Fibrinolytic Agents
Brain Diseases
Neuroprotective Agents
Cerebrovascular Disorders
Necrosis
Fibrin Modulating Agents
Aspirin
Brain Ischemia
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Cilostazol
Stroke

Cyclooxygenase Inhibitors
Vascular Diseases
Anti-Asthmatic Agents
Central Nervous System Diseases
Ischemia
Cardiovascular Agents
Phosphodiesterase Inhibitors
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Brain Infarction
Peripheral Nervous System Agents
Infarction
Antirheumatic Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Brain Diseases
Neuroprotective Agents
Cerebrovascular Disorders
Fibrin Modulating Agents
Necrosis
Pathologic Processes
Aspirin

Sensory System Agents
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Cilostazol
Cyclooxygenase Inhibitors
Nervous System Diseases
Stroke
Vascular Diseases
Anti-Asthmatic Agents
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 11, 2009