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Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

Primary Purpose

Cerebral Infarction

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cilostazol 200mg/day Oral
Aspirin 100mg/day Oral
Sponsored by
Otsuka Beijing Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Infarction focused on measuring Cerebral infarction, Prevention, Cilostazol, Aspirin, Stroke, Clinical trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. - -

Sites / Locations

  • 1st affiliated hospital, Guangzhou Zhongshan University
  • 2nd affiliated hospital, Guangzhou medical college
  • 1st affiliated Jilin University
  • 1st affiliated hospital, Xi'an Jiatong University
  • 2nd affiliated hospital, Zhejiang University
  • 1st affiliated hospital, Peking University
  • 3rd affiliated hospital, Peking University
  • General Hospital of Beijing Military Area of PLA
  • Renmin Hospital, Peking University
  • Huashan Hospital Shanghai Fudan University
  • Renji Hospital, Shanghai 2nd medical university
  • General Hospital, Tianjin Medical University

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
March 15, 2006
Sponsor
Otsuka Beijing Research Institute
Collaborators
Zhejiang Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00202020
Brief Title
Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke
Official Title
Cilostazol Stroke Prevention Study-a Randomized, Double Blind, Double Dummy, Parallel Comparative, Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Beijing Research Institute
Collaborators
Zhejiang Otsuka Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
Keywords
Cerebral infarction, Prevention, Cilostazol, Aspirin, Stroke, Clinical trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
720 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cilostazol 200mg/day Oral
Intervention Type
Drug
Intervention Name(s)
Aspirin 100mg/day Oral
Primary Outcome Measure Information:
Title
Recurrence of stroke(cerebral infarction/haemorrhage/subarachnoid haemorrhage)
Secondary Outcome Measure Information:
Title
Recurrence of cerebral infarction detected in MRI
Title
Death due to cerebral vascular events
Title
Myocardial infarction
Title
Vascular events(acute artery thrombosis/embolism, pneumonia embolism, venous thrombosis, angina pectoris)
Title
TIA
Title
Death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 - 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. - -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi N Huang, Professor
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st affiliated hospital, Guangzhou Zhongshan University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
2nd affiliated hospital, Guangzhou medical college
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
1st affiliated Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
1st affiliated hospital, Xi'an Jiatong University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
2nd affiliated hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
1st affiliated hospital, Peking University
City
Beijing
Country
China
Facility Name
3rd affiliated hospital, Peking University
City
Beijing
Country
China
Facility Name
General Hospital of Beijing Military Area of PLA
City
Beijing
Country
China
Facility Name
Renmin Hospital, Peking University
City
Beijing
Country
China
Facility Name
Huashan Hospital Shanghai Fudan University
City
Shanghai
Country
China
Facility Name
Renji Hospital, Shanghai 2nd medical university
City
Shanghai
Country
China
Facility Name
General Hospital, Tianjin Medical University
City
Tianjin
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22949472
Citation
Liu W, Liu R, Sun W, Peng Q, Zhang W, Xu E, Cheng Y, Ding M, Li Y, Hong Z, Wu J, Zeng J, Yao C, Huang Y; CASISP Study Group. Different impacts of blood pressure variability on the progression of cerebral microbleeds and white matter lesions. Stroke. 2012 Nov;43(11):2916-22. doi: 10.1161/STROKEAHA.112.658369. Epub 2012 Sep 4.
Results Reference
derived
PubMed Identifier
18456558
Citation
Huang Y, Cheng Y, Wu J, Li Y, Xu E, Hong Z, Li Z, Zhang W, Ding M, Gao X, Fan D, Zeng J, Wong K, Lu C, Xiao J, Yao C; Cilostazol versus Aspirin for Secondary Ischaemic Stroke Prevention cooperation investigators. Cilostazol as an alternative to aspirin after ischaemic stroke: a randomised, double-blind, pilot study. Lancet Neurol. 2008 Jun;7(6):494-9. doi: 10.1016/S1474-4422(08)70094-2. Epub 2008 May 2. Erratum In: Lancet Neurol. 2008 Aug;7(8):675.
Results Reference
derived

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Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

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