Cerebral InfarctionPhase 4TOSS-2NCT00130039
Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II
A Phase 4 study testing clopidogrel and Cilostazol in people with Cerebral Infarction and Atherosclerosis, run by Asan Medical Center at 19 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Cerebral Infarction, Atherosclerosis
- What is being tested?
- clopidogrel and Cilostazol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 19 sitesin 4 countries
- Study dates
- Aug 2005to Jan 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
South Korea13 sites
Hallym University Sacred Heart Hospital
Anyang, Kyunggi, 430-070
Dongguk University International Hospital
Goyang, Kyoungki-do, 410-773
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, 411-706
Inha University Hospital
Inchon, 400-103
Seoul National University Bundang Hospital
Seongnam
Konkuk Univ. Hospital
Seoul, Gwangjin-gu Hwayang-dong, 143-729
Soonchunhyang University Hospital
Seoul, Seoul, 140-743
Seoul National University Hospital
Seoul, 110-744
Kangdong Sacred Heart Hospital, Hallym University
Seoul, 134-701
Samsung Medical Center
Seoul, 135-710
Asan Medical Center
Seoul, 138-736
Seoul National University Boramae Hospital
Seoul, 156-707
Eulji Hospital
Seoul, 280-1
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Philippines2 sites
Philippine General Hospital
Manila
University of Santo Tomas Hospital
Manila
About this study
Official title: Trial for Efficacy and Safety of Cilostazol on the Progression of Symptomatic Intracranial Stenosis Comparing Clopidogrel
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).
Read the 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 (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
- Cerebral Infarction, Atherosclerosis
- Being tested
- clopidogrel, Cilostazol
- Keywords
- Infarction, Cerebral, cilostazol, stenosis, atherosclerosis, clopidogrel
- Medical subject headings
- Cerebral Infarction, Atherosclerosis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
Also called Plavix, produced by Sanofi-Aventis.
Clopidogrel 75mg once a day plus placebo of cilostazol twice a day
CilostazolDrug
Also called cilostazol produced by Korea Otsuka Pharmaceutical
Cilostazol 100mg twice a day plus placebo of clopidogrel once a day
| Study group | Role | What they receive |
|---|---|---|
| cilostazol | Experimental | cilostazol 100mg bid plus placebo of clopidogrel Receives: Drug: Cilostazol |
| Clopidogrel | Active comparator | clopidogrel 75mg qd and matching placebo of cilostazol Receives: Drug: clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months after treatment
Secondary outcomes (5)
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.
Measured: 7 months after treatment
Number of Participants With Stroke Events
including nonfatal ischemic stroke, nonfatal hemorrhagic stroke and fatal stroke
Measured: upto 7 months after randomization
Number of Participants With Overall Cardiovascular Events
including nonfatal stroke, nonfatal myocardial infarction and vascular death.
Measured: 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
Measured: 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
Measured: upto 7 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Otsuka International Asia Arab
- Investigators
- Sun U. Kwon, MD, PhD, Principal investigator, Asan Medical Center, Univsersity of Ulsan, Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130039
- Sponsor's protocol ID
- TOSS-2
- Acronym
- TOSS-2
- Status last verified
- Nov 2009
- First submitted
- 11 Aug 2005
- Last updated
- 12 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24957314Kim 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.
PubMed 24315720Jung 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.
PubMed 22910894Kim 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.
PubMed 22539545Kwon 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.
PubMed 21799173
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial for Efficacy and Safety of Cilostazol on the Progression of Symptomatic Intracranial Stenosis Comparing Clopidogrel
- ClinicalTrials.gov ID
- NCT00130039
- Acronym / sponsor ID
- TOSS-2 / TOSS-2
- Conditions
- Cerebral Infarction, Atherosclerosis
- Keywords
- Infarction, Cerebral, cilostazol, stenosis, atherosclerosis, clopidogrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korea Otsuka International Asia Arab
- Study start
- Aug 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 15 Aug 2005 (estimated)
- Results
- Posted 1 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 (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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cilostazol | Experimental | Drug: Cilostazolcilostazol 100mg bid plus placebo of clopidogrel |
| Clopidogrel | Active comparator | Drug: clopidogrelclopidogrel 75mg qd and matching placebo of cilostazol |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clopidogrelAlso: Plavix, produced by Sanofi-Aventis.Clopidogrel 75mg once a day plus placebo of cilostazol twice a day | Drug | Clopidogrel |
| CilostazolAlso: cilostazol produced by Korea Otsuka PharmaceuticalCilostazol 100mg twice a day plus placebo of clopidogrel once a day | Drug | cilostazol |
Primary outcome
Number of Participants With Progression of Symptomatic Intracranial Stenosis
Time frame: 7 months after treatment
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.
5 secondary outcomes
Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI
Time frame: 7 months after treatment
Number of Participants With Stroke Events
Time frame: upto 7 months after randomization
Number of Participants With Overall Cardiovascular Events
Time frame: upto 7 months after randomization
Number of Patients With Ipsilateral Ischemic Stroke Rate
Time frame: upto 7 months after randomization
Numbers of Fatal or Major Bleeding Complications
Time frame: upto 7 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24957314Park 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.
- Derived from this study: PubMed 24315720Kim 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.
- Derived from this study: PubMed 22910894Jung 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.
- Derived from this study: PubMed 22539545Kim 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.
- Derived from this study: PubMed 21799173Kwon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun U. Kwon, MD, PhD principal investigator
Asan Medical Center, Univsersity of Ulsan, Medical College
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clopidogrel and Cilostazol in people with Cerebral Infarction and Atherosclerosis, run by Asan Medical Center at 19 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in South Korea, Hong Kong, Philippines, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Progression of Symptomatic Intracranial Stenosis (time frame: 7 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00130039, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.