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| Name | Class |
|---|---|
| Korea Otsuka International Asia Arab | INDUSTRY |
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This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1 segment of Middle cerebral artery (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 magnetic resonance angiogram (MRA).
[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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cilostazol | Experimental | cilostazol 100mg bid plus placebo of clopidogrel |
|
| Clopidogrel | Active Comparator | clopidogrel 75mg qd and matching placebo of cilostazol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clopidogrel | Drug | Clopidogrel 75mg once a day plus placebo of cilostazol twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Progression of Symptomatic Intracranial Stenosis | Blind reviewers classified the presence and severity of stenosis on middle cerebral arteries and basilar artery on magnetic resonance angiogram (MRA) into 5 grades; normal, mild, moderate, severe and occlusion. Progression was defined as worsening of stenosis by 1 or more grades on final MRA as compared with the baseline MRA. The progression of symptomatic stenosis is defined as 1 or more grade worsening of the stenosis on the symptomatic artery on MRA. | 7 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI | number of patients with new ischemic lesions on FLAIR (Fluid attenuation inversion recovery) images of follow-up MRI, which were determined by slice to slice comparison with baseline MRI. | 7 months after treatment |
| Number of Participants With Stroke Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun U. Kwon, MD, PhD | Asan Medical Center, Univsersity of Ulsan, Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | Hong Kong | ||||
| Queen Mary Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24957314 | Derived | 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. | |
| 24315720 |
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The excluded patients did not satisfy the definition of the symptomatic stenosis of our study protocol.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Cilostazol | cilostazol 100mg twice a day plus placebo of clopidogrel |
| FG001 | Clopidogrel | clopidogrel 75mg per day and matching placebo of cilostazol |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cilostazol | Drug | Cilostazol 100mg twice a day plus placebo of clopidogrel once a day |
|
|
including nonfatal ischemic stroke, nonfatal hemorrhagic stroke and fatal stroke |
| upto 7 months after randomization |
| Number of Participants With Overall Cardiovascular Events | including nonfatal stroke, nonfatal myocardial infarction and vascular death. | upto 7 months after randomization |
| Number of Patients With Ipsilateral Ischemic Stroke Rate | ischemic stroke event which occured in the vascular territory of initial symptomatic stenosis | upto 7 months after randomization |
| Numbers of Fatal or Major Bleeding Complications | life-threatening or fatal bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood | upto 7 months after randomization |
| Hong Kong |
| Hong Kong |
| Philippine General Hospital | Manila | Philippines |
| University of Santo Tomas Hospital | Manila | Philippines |
| Konkuk Univ. Hospital | Seoul | Gwangjin-gu Hwayang-dong | 143-729 | South Korea |
| Inje University Ilsan Paik Hospital | Goyang-si | Gyeonggi-do | 411-706 | South Korea |
| Dongguk University International Hospital | Goyang | Kyoungki-do | 410-773 | South Korea |
| Hallym University Sacred Heart Hospital | Anyang | Kyunggi | 430-070 | South Korea |
| Soonchunhyang University Hospital | Seoul | Seoul | 140-743 | South Korea |
| Inha University Hospital | Inchon | 400-103 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Kangdong Sacred Heart Hospital, Hallym University | Seoul | 134-701 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Seoul National University Boramae Hospital | Seoul | 156-707 | South Korea |
| Eulji Hospital | Seoul | 280-1 | South Korea |
| Ramathibodi Hospital | Bangkok | Thailand |
| Siriraj Hospital | Bangkok | Thailand |
| Derived |
| 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. |
| 22910894 | Derived | 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. |
| 22539545 | Derived | 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. |
| 21799173 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cilostazol | cilostazol 100mg twice a day plus placebo of clopidogrel |
| BG001 | Clopidogrel | clopidogrel 75mg per day and matching placebo of cilostazol |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Progression of Symptomatic Intracranial Stenosis | Blind reviewers classified the presence and severity of stenosis on middle cerebral arteries and basilar artery on magnetic resonance angiogram (MRA) into 5 grades; normal, mild, moderate, severe and occlusion. Progression was defined as worsening of stenosis by 1 or more grades on final MRA as compared with the baseline MRA. The progression of symptomatic stenosis is defined as 1 or more grade worsening of the stenosis on the symptomatic artery on MRA. | Posted | May 2009 | Number | participants | 7 months after treatment |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI | number of patients with new ischemic lesions on FLAIR (Fluid attenuation inversion recovery) images of follow-up MRI, which were determined by slice to slice comparison with baseline MRI. | this analysis included the patients who had performed follow-up FLAIR imaging | Posted | May 2009 | Number | pariticipants | 7 months after treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Stroke Events | including nonfatal ischemic stroke, nonfatal hemorrhagic stroke and fatal stroke | this outcome analysis performed on the intention to treat (ITT) method | Posted | May 2009 | Number | participants | upto 7 months after randomization |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Overall Cardiovascular Events | including nonfatal stroke, nonfatal myocardial infarction and vascular death. | this outcome analysis was done intention to treat method | Posted | May 2009 | Number | participants | upto 7 months after randomization |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Patients With Ipsilateral Ischemic Stroke Rate | ischemic stroke event which occured in the vascular territory of initial symptomatic stenosis | this outcome analysis was done ITT method | Posted | May 2009 | Number | participants | upto 7 months after randomization |
|
| |||||||||||||||||||||||||||||
| Secondary | Numbers of Fatal or Major Bleeding Complications | life-threatening or fatal bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood | this outcome analysis was done ITT method | Posted | May 2009 | Number | events | upto 7 months after randomization |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cilostazol | cilostazol 100mg twice a day plus placebo of clopidogrel | 54 | 232 | 232 | 232 | ||
| EG001 | Clopidogrel | clopidogrel 75mg per day and matching placebo of cilostazol | 54 | 225 | 225 | 225 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 'Blood tinged loose stool | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| multi-organ failure | Infections and infestations | Systematic Assessment |
| ||
| abnormal involuntary movement | Nervous system disorders | Systematic Assessment |
| ||
| acute bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| cerebral infarction | Nervous system disorders |
| |||
| cerebral hemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| aneurysm unruptured | Vascular disorders | Systematic Assessment |
| ||
| gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| GI bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| traffic accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| otitis media | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| cystitis | Renal and urinary disorders | Systematic Assessment |
| ||
| cataract operation | Eye disorders | Non-systematic Assessment |
| ||
| depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| diabetes complications | Endocrine disorders | Non-systematic Assessment |
| ||
| general weakness | Nervous system disorders | Non-systematic Assessment |
| ||
| vestibular neuronitis | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| fracture or other joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| infection | Infections and infestations | Systematic Assessment |
| ||
| headache | Nervous system disorders | Non-systematic Assessment |
| ||
| edema | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| seizure | Nervous system disorders | Non-systematic Assessment |
| ||
| severe hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Non-systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| petechia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| palpitation | Cardiac disorders | Non-systematic Assessment |
| ||
| urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| epigastric soreness | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| GI bleedings | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| others | Social circumstances | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sun U. Kwon, MD, PhD, Prof | Asan Medical Center, University of Ulsan | 82-2-3010-3960 | sukwon@amc.seoul.kr |
| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| D050197 | Atherosclerosis |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D011804 | Quinolines |
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| >=65 years |
|
| Male |
|
| Hong Kong |
|
| Thailand |
|
| Korea, Republic of |
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