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Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II (TOSS-2)
This study has been completed.
Study NCT00130039   Information provided by Asan Medical Center
Study First Received: August 11, 2005   Last Updated: January 4, 2010   History of Changes
Results First Received: October 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Control: Active Control;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cerebral Infarction
Atherosclerosis
Interventions: Drug: clopidogrel
Drug: Cilostazol

  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

507 patients were registered www.toss2.com from 20 centers of 4 countries (Korea, Hongkong, Thailand, Philippines). 50 patients were excluded during case verification process because they did not satisfy patient's eligibility criteria.

finally 457 patients were randomized into cilostazol or clopidogrel group


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The excluded patients did not satisfy the definition of the symptomatic stenosis of our study protocol.

Reporting Groups
  Description
Cilostazol cilostazol 100mg twice a day plus placebo of clopidogrel
Clopidogrel clopidogrel 75mg per day and matching placebo of cilostazol

Participant Flow:   Overall Study
  Cilostazol Clopidogrel
STARTED   232     225  
COMPLETED   202[1]   207[2]
NOT COMPLETED   30     18  
      Withdrawal by Subject               15                 11  
      Lost to Follow-up               3                 1  
      Adverse Event               4                 2  
      Physician Decision               3                 0  
      clinical events without follow up MRI               5                 4  
[1] full analysis set
[2] full analysis set



  Baseline Characteristics
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Reporting Groups
  Description
Cilostazol cilostazol 100mg twice a day plus placebo of clopidogrel
Clopidogrel clopidogrel 75mg per day and matching placebo of cilostazol

Baseline Measures
  Cilostazol Clopidogrel Total
Number of Participants  
[units: participants]
232 225 457
Age  
[units: participants]
     
<=18 years 0 0 0
Between 18 and 65 years 93 112 205
>=65 years 139 113 252
Age  
[units: years]
Mean ± Standard Deviation
66.42 ± 11.33 64.58 ± 11.11 65.52 ± 11.24
Gender  
[units: participants]
     
Female 110 113 223
Male 122 112 234
Region of Enrollment  
[units: participants]
     
Philippines 5 5 10
Hong Kong 11 12 23
Thailand 6 5 11
Korea, Republic of 210 203 413



  Outcome Measures
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1.  Primary:   Number of Participants With Progression of Symptomatic Intracranial Stenosis   [ Time Frame: 7 months after treatment ]

2.  Secondary:   Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI   [ Time Frame: 7 months after treatment ]

3.  Secondary:   Number of Participants With Stroke Events   [ Time Frame: upto 7 months after randomization ]

4.  Secondary:   Number of Participants With Overall Cardiovascular Events   [ Time Frame: upto 7 months after randomization ]

5.  Secondary:   Number of Patients With Ipsilateral Ischemic Stroke Rate   [ Time Frame: upto 7 months after randomization ]

6.  Secondary:   Numbers of Fatal or Major Bleeding Complications   [ Time Frame: upto 7 months after randomization ]


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Sun U. Kwon, MD, PhD, Prof
Organization: Asan Medical Center, University of Ulsan
phone: 82-2-3010-3960
e-mail: sukwon@amc.seoul.kr


No publications provided


Responsible Party: Asan Medical Center ( Sun U. Kwon )
Study ID Numbers: TOSS-2
Study First Received: August 11, 2005
Results First Received: October 23, 2009
Last Updated: January 4, 2010
ClinicalTrials.gov Identifier: NCT00130039     History of Changes
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)