Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II
NCT ID: NCT00130039
Last Updated: 2010-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
457 participants
INTERVENTIONAL
2005-08-31
2009-01-31
Brief Summary
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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 magnetic resonance angiogram (MRA).
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Detailed Description
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\[Trial Design\] Double-Blind, Active-Controlled, Randomized, Multicenter Trial
\[Participants\] Acute ischemic stroke patients with symptomatic intracranial arterial stenosis
\[Methods\]
* Double-Blind, Active-Controlled, Randomized, Multicenter Trial
* Investigational product (Double Dummy Method):
Cilostazol 200mg (100mg twice per day) versus clopidogrel 75mg
* Concomitant medication: Aspirin 100 (75-150) mg per day
* Medication Duration: 7 months
\[Outcome Variables\]
Primary Outcome Variable:
* Progression rate of symptomatic intracranial arterial stenosis
Secondary outcome variables:
* The occurrence of new MRI (magnetic resonance image) lesion on follow-up MRI
* Stroke events
* Overall cardiovascular events: stroke, acute coronary syndrome, vascular death
* Ipsilateral ischemic stroke rate
* Fatal or major bleeding complications
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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cilostazol
cilostazol 100mg bid plus placebo of clopidogrel
Cilostazol
Cilostazol 100mg twice a day plus placebo of clopidogrel once a day
Clopidogrel
clopidogrel 75mg qd and matching placebo of cilostazol
clopidogrel
Clopidogrel 75mg once a day plus placebo of cilostazol twice a day
Interventions
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clopidogrel
Clopidogrel 75mg once a day plus placebo of cilostazol twice a day
Cilostazol
Cilostazol 100mg twice a day plus placebo of clopidogrel once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: more than 35 years of age
* Patient with significant focal stenosis in the M1 segment of middle cerebral artery (MCA) or basilar artery (BA) with acute ischemic lesions on magnetic resonance imaging (MRI) within the vascular territory of the stenosed artery.
Exclusion Criteria
* Patients with potential cardiac embolic source; prosthetic valve, atrial fibrillation, atrial flutter, left atrial/atrial appendage thrombus, sick sinus syndrome, left ventricular thrombus, dilated cardiomyopathy, akinetic or hypokinetic left ventricular segment, atrial myxoma, Infective endocarditis, mitral valve stenosis or prolapse, mitral annuls calcification, left atrial turbulence, nonbacterial endocarditis, congestive heart failure, recent myocardial infarction (within 4 weeks)
* Patients with more than 50% stenosis in the parent artery of symptomatic stenosis
* Bleeding diathesis
* Chronic liver disease (ALT \> 100 or AST \> 100) or chronic renal disease (creatinine \> 3.0mg/dl)
* Anemia (hemoglobin \< 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
* Nonatherosclerotic vasculopathy; patients with clinical characteristics suggesting arterial dissection, moyamoya disease, Takayasu's arteritis, radiation associated angiopathy, and other vasculitis.
* Severe stroke: NIH stroke scale : more than 16
* Pregnant or lactating patients
* Chronic user of NSAIDs
* Thrombolytic therapy for the symptomatic stenosis
* Symptomatic stenosis scheduled for angioplasty
* Patients with pacemaker or any other contraindications to MRI
35 Years
ALL
No
Sponsors
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Korea Otsuka International Asia Arab
INDUSTRY
Asan Medical Center
OTHER
Responsible Party
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Asan Medical Center
Principal Investigators
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Sun U. Kwon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center, Univsersity of Ulsan, Medical College
Locations
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Prince of Wales Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Philippine General Hospital
Manila, , Philippines
University of Santo Tomas Hospital
Manila, , Philippines
Konkuk Univ. Hospital
Seoul, Gwangjin-gu Hwayang-dong, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
Dongguk University International Hospital
Goyang, Kyoungki-do, South Korea
Hallym University Sacred Heart Hospital
Anyang, Kyunggi, South Korea
Soonchunhyang University Hospital
Seoul, Seoul, South Korea
Inha University Hospital
Inchon, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangdong Sacred Heart Hospital, Hallym University
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Seoul National University Boramae Hospital
Seoul, , South Korea
Eulji Hospital
Seoul, , South Korea
Ramathibodi Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Countries
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References
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Park TH, Lee JS, Park SS, Ko Y, Lee SJ, Lee KB, Lee J, Kang K, Park JM, Choi JC, Kim DE, Cho YJ, Kim JT, Kim DH, Cha JK, Han MK, Lee J, Oh MS, Yu KH, Lee BC, Bae HJ, Hong KS. Safety and efficacy of intravenous recombinant tissue plasminogen activator administered in the 3- to 4.5-hour window in Korea. J Stroke Cerebrovasc Dis. 2014 Aug;23(7):1805-12. doi: 10.1016/j.jstrokecerebrovasdis.2014.04.027. Epub 2014 Jun 21.
Kim BJ, Rha JH, Kim SR, Kim DE, Kim HY, Lee JH, Bae HJ, Han MK, Kang DW, Ratanakorn D, Kim JS, Kwon SU. The effect of cilostazol on carotid intima-media thickness progression in patients with symptomatic intracranial atherosclerotic stenosis. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):1164-70. doi: 10.1016/j.jstrokecerebrovasdis.2013.10.007. Epub 2013 Dec 6.
Jung JM, Kang DW, Yu KH, Koo JS, Lee JH, Park JM, Hong KS, Cho YJ, Kim JS, Kwon SU; TOSS-2 Investigators. Predictors of recurrent stroke in patients with symptomatic intracranial arterial stenosis. Stroke. 2012 Oct;43(10):2785-7. doi: 10.1161/STROKEAHA.112.659185. Epub 2012 Aug 21.
Kim DE, Kim JY, Jeong SW, Cho YJ, Park JM, Lee JH, Kang DW, Yu KH, Bae HJ, Hong KS, Koo JS, Lee SH, Lee BC, Han MK, Rha JH, Lee YS, Kim GM, Chae SL, Kim JS, Kwon SU. Association between changes in lipid profiles and progression of symptomatic intracranial atherosclerotic stenosis: a prospective multicenter study. Stroke. 2012 Jul;43(7):1824-30. doi: 10.1161/STROKEAHA.112.653659. Epub 2012 Apr 26.
Kwon SU, Hong KS, Kang DW, Park JM, Lee JH, Cho YJ, Yu KH, Koo JS, Wong KS, Lee SH, Lee KB, Kim DE, Jeong SW, Bae HJ, Lee BC, Han MK, Rha JH, Kim HY, Mok VC, Lee YS, Kim GM, Suwanwela NC, Yun SC, Nah HW, Kim JS. Efficacy and safety of combination antiplatelet therapies in patients with symptomatic intracranial atherosclerotic stenosis. Stroke. 2011 Oct;42(10):2883-90. doi: 10.1161/STROKEAHA.110.609370. Epub 2011 Jul 28.
Other Identifiers
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TOSS-2
Identifier Type: -
Identifier Source: org_study_id
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