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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 11, 2005 | ||||||||
| Last Updated Date | March 12, 2007 | ||||||||
| Start Date ICMJE | August 2005 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Progression rate of symptomatic intracranial stenosis | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00130039 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II | ||||||||
| Official Title ICMJE | Trial for Efficacy and Safety of Cilostazol on the Progression of Symptomatic Intracranial Stenosis Comparing Clopidogrel | ||||||||
| Brief Summary | This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1 segment of MCA or basilar artery). They will be randomly assigned into cilostazol group or clopidogrel group. Every patients will take 100mg of aspirin a day additionally. The primary outcome variable of this study is Progression rate of symptomatic intracranial stenosis on MRA. |
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| Detailed Description | [Goal] To Reveal the Effect and Safety of Cilostazol Compared with Clopidogrel on the Prevention of the Progression of Symptomatic Intracranial Arterial Stenosis. [Trial Design] Double-Blind, Active-Controlled, Randomized, Multicenter Trial [Participants] Acute ischemic stroke patients with symptomatic intracranial arterial stenosis [Methods]
Cilostazol 200mg (100mg twice per day) versus clopidogrel 75mg
[Outcome Variables] Primary Outcome Variable:
Secondary outcome variables:
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: cilostazol versus clopidogrel | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 480 | ||||||||
| Completion Date | December 2008 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 35 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Hong Kong, Korea, Republic of, Philippines, Thailand | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00130039 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | TOSS-2 | ||||||||
| Study Sponsor ICMJE | Asan Medical Center | ||||||||
| Collaborators ICMJE | Korea Otsuka International Asia Arab | ||||||||
| Investigators ICMJE |
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| Information Provided By | Asan Medical Center | ||||||||
| Verification Date | August 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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