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Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II (TOSS-2)
This study is currently recruiting participants.
Verified by Asan Medical Center, August 2005
Sponsors and Collaborators: Asan Medical Center
Korea Otsuka International Asia Arab
Information provided by: Asan Medical Center
ClinicalTrials.gov Identifier: NCT00130039
  Purpose

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.


Condition Intervention Phase
Cerebral Infarction
Atherosclerosis
Drug: cilostazol versus clopidogrel
Phase IV

Drug Information available for: Clopidogrel Clopidogrel Bisulfate Cilostazol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Trial for Efficacy and Safety of Cilostazol on the Progression of Symptomatic Intracranial Stenosis Comparing Clopidogrel

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Progression rate of symptomatic intracranial stenosis

Secondary Outcome Measures:
  • The occurrence of new MRI 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

Estimated Enrollment: 480
Study Start Date: August 2005
Estimated Study Completion Date: December 2008
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]

  • 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 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
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cerebral infarction within 2 weeks from the onset or TIA with corresponding acute ischemic brain lesions on MRI within 2 weeks from the onset
  • 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 any contraindications to the treatment with antiplatelet therapy
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130039

Contacts
Contact: Sun U Kwon, MD, PhD 82-2-3010-3960 sunuck@amc.seoul.kr
Contact: Dong W Kang, MD, PhD 82-2-3010-3968 dwkang@amc.seooul.kr

Locations
Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Vincent CT Mok, MD         vctmok@cuhk.edu.hk    
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Raymond TF Cheung, MD, PhD         rtcheung@hkucc.hku.hk    
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sun U. Kwon, MD, PhD     82-2-3010-3960     sunuck@amc.seoul.kr    
Sub-Investigator: Jong S Kim, MD, PhD            
Sub-Investigator: Dong W Kang, MD, PhD            
Eulji Hospital Recruiting
Seoul, Korea, Republic of, 280-1
Contact: Ja-Seong Koo, MD     82-2-970-8609     kjs1406@eulji.or.kr    
Sub-Investigator: Jong-Moo Park, MD            
Seoul National University Bundang Hospital Recruiting
Sungnam, Korea, Republic of
Contact: Moon-Ku Han, MD     82-31-787-7464     blue4han@chollian.net    
Sub-Investigator: Hee-Joon Bae, MD, Ph.D            
Inha University Hospital Recruiting
Inchon, Korea, Republic of, 400-103
Contact: Joung-Ho Rha, MD     +82-32-890-3668     jhrha@inha.ac.kr    
Principal Investigator: Joung-Ho Rha, MD            
Kangdong Sacred Heart Hospital, Hallym University Recruiting
SEOUL, Korea, Republic of, 134-701
Contact: Ju-Hun Lee     82-2-2224-2695     leeforte@medimail.co.kr    
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Seung-Hoon Lee, Prof.     82-2-2072-1014     sb0516@snu.ac.kr    
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Gyeong-Moon Kim, M.D.     82-2-3410-3598     kimgm@smc.samsung.co.kr    
Seoul National University Boramae Hospital Recruiting
Seoul, Korea, Republic of, 156-707
Contact: Yong-Seok Lee, MD     82-2-840-2492     lys@brm.co.kr    
Soonchunhyang University Hospital Recruiting
Seoul, Korea, Republic of, 140-743
Contact: Kyung Bok Lee, M.D.     +82-2-709-9262     kblee@hosp.sch.ac.kr    
Principal Investigator: Kyung Bok Lee, M.D.            
Korea, Republic of, Gwangjin-gu Hwayang-dong
Konkuk Univ. Hospital Recruiting
Seoul, Gwangjin-gu Hwayang-dong, Korea, Republic of, 143-729
Contact: Hahn Young Kim     82-2-2030-7563     drdpl@freechal.com    
Principal Investigator: Hahn Young Kim, MD            
Korea, Republic of, Gyeonggi-do
Inje University Ilsan Paik Hospital Recruiting
Goyang, Gyeonggi-do, Korea, Republic of, 411-706
Contact: Keun-Sik Hong, MD/PhD     82-31-910-7680     nrhks@ilsanpaik.ac.kr    
Sub-Investigator: Yong-Jin Cho, MD, PhD            
Korea, Republic of, Kyoungki-do
Dongguk University International Hospital Recruiting
Goyang, Kyoungki-do, Korea, Republic of, 410-773
Contact: Dong-Eog Kim, MD, PhD     031-961-7200     kdongeog@duih.org    
Principal Investigator: Dong-Eog Kim, MD, PhD            
Sub-Investigator: Sang-Wook Jeong, MD, PhD            
Korea, Republic of, Kyunggi
Hallym University Sacred Heart Hospital Recruiting
Anyang, Kyunggi, Korea, Republic of, 430-070
Contact: Byung-Chul Lee, MD. PhD.     +82-31-380-3741     ssbrain@hallym.ac.kr    
Contact: Kyung-Ho Yu, MD.     +82-31-380-3743     ykh1030@hallym.or.kr    
Sub-Investigator: Byung-Chul Lee, MD. PhD.            
Principal Investigator: Kyung-Ho Yu, MD.            
Philippines
University of Santo Tomas Hospital Recruiting
Manila, Philippines
Contact: Jose Navarro         jc.navarro@icable.ph    
Philippine General Hospital Recruiting
Manila, Philippines
Contact: Cristina San Jose         czsanjose@yahoo.com    
Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand
Contact: Niphon Poungvarin, M.D.         sinpg@mahidol.ac.th    
Ramathibodi Hospital Recruiting
Bangkok, Thailand
Contact: Disya Ratanakorn, M.D.         radrt@mahidol.ac.th    
Sponsors and Collaborators
Asan Medical Center
Korea Otsuka International Asia Arab
Investigators
Principal Investigator: Sun U. Kwon, MD, PhD Asan Medical Center, Univsersity of Ulsan, Medical College
  More Information

webpage for review of the case eligibility and randomization. It shows also the basic statistical data for the current enrollment  This link exits the ClinicalTrials.gov site

Study ID Numbers: TOSS-2
Study First Received: August 11, 2005
Last Updated: March 12, 2007
ClinicalTrials.gov Identifier: NCT00130039  
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:
Infarction, Cerebral
cilostazol
stenosis
atherosclerosis
clopidogrel

Study placed in the following topic categories:
Atherosclerosis
Arterial Occlusive Diseases
Cilostazol
Cerebral Infarction
Stroke
Disease Progression
Vascular Diseases
Central Nervous System Diseases
Constriction, Pathologic
Arteriosclerosis
Ischemia
Brain Diseases
Cerebrovascular Disorders
Necrosis
Clopidogrel
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Nervous System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Fibrin Modulating Agents
Phosphodiesterase Inhibitors
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009