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Sponsors and Collaborators: |
Asan Medical Center Korea Otsuka International Asia Arab |
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Information provided by: | Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT00130039 |
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 |
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 |
Estimated Enrollment: | 480 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | December 2008 |
[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:
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Sun U. Kwon, MD, PhD | Asan Medical Center, Univsersity of Ulsan, Medical College |
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) |
Infarction, Cerebral cilostazol stenosis atherosclerosis clopidogrel |
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 |
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 |