Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00234065
First received: October 4, 2005
Last updated: June 9, 2011
Last verified: June 2011
Results First Received: April 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Cerebral Infarction
Interventions: Drug: Cilostazol
Drug: Aspirin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with non-cardioembolic ischemic stroke have been recruited at 278 study sites in Japan between December, 2003, and October, 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No screening period

Reporting Groups
  Description
Cilostazol cilostazol, oral tablet, 100 mg cilostazol
Aspirin Aspirin, oral tablet, 81 mg aspirin

Participant Flow:   Overall Study
    Cilostazol     Aspirin  
STARTED     1356     1360  
COMPLETED     881     1004  
NOT COMPLETED     475     356  
Adverse Event                 268                 166  
Withdrawal by Subject                 73                 56  
Physician Decision                 23                 22  
Not Classified                 111                 112  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cilostazol cilostazol, oral tablet, 100 mg cilostazol
Aspirin Aspirin, oral tablet, 81 mg aspirin
Total Total of all reporting groups

Baseline Measures
    Cilostazol     Aspirin     Total  
Number of Participants  
[units: participants]
  1337     1335     2672  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     681     685     1366  
>=65 years     656     650     1306  
Age  
[units: years]
Mean ± Standard Deviation
  63.5  ± 9.2     63.4  ± 9.0     63.4  ± 9.1  
Gender  
[units: participants]
     
Female     378     378     756  
Male     959     957     1916  
Region of Enrollment  
[units: participants]
     
Japan     1337     1335     2672  



  Outcome Measures
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1.  Primary:   Numbers of Patients With First Occurence of Stroke   [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months]) ]

2.  Secondary:   Number of Patients With First Recurrence of Cerebral Infarction   [ Time Frame: From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) ]

3.  Secondary:   Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease   [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) ]

4.  Secondary:   Number of Deaths From Any Cause   [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) ]

5.  Secondary:   Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events   [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) ]

6.  Other Pre-specified:   Number of Patients With First Occurrence of Haemorrhagic Event   [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Masahiko Abe, Director Cardiovascular Projects
Organization: Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
phone: +81-6-6943-7722 ext 2545
e-mail: abems@otsuka.jp


Publications of Results:

Responsible Party: Katsuhisa Saito, OPCJ
ClinicalTrials.gov Identifier: NCT00234065     History of Changes
Other Study ID Numbers: C02100-002, JapicCTI-050034, UMIN-CTR-C000000129
Study First Received: October 4, 2005
Results First Received: April 19, 2011
Last Updated: June 9, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare