Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II (TOSS-2)
This study has been completed.
Sponsor:
Asan Medical Center
Collaborator:
Korea Otsuka International Asia Arab
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00130039
First received: August 11, 2005
Last updated: January 4, 2010
Last verified: November 2009
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebral Infarction Atherosclerosis |
Drug: clopidogrel Drug: Cilostazol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Trial for Efficacy and Safety of Cilostazol on the Progression of Symptomatic Intracranial Stenosis Comparing Clopidogrel |
Resource links provided by NLM:
Further study details as provided by Asan Medical Center:
Primary Outcome Measures:
- Number of Participants With Progression of Symptomatic Intracranial Stenosis [ Time Frame: 7 months after treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI [ Time Frame: 7 months after treatment ] [ Designated as safety issue: No ]
- Number of Participants With Stroke Events [ Time Frame: upto 7 months after randomization ] [ Designated as safety issue: No ]
- Number of Participants With Overall Cardiovascular Events [ Time Frame: upto 7 months after randomization ] [ Designated as safety issue: No ]
- Number of Patients With Ipsilateral Ischemic Stroke Rate [ Time Frame: upto 7 months after randomization ] [ Designated as safety issue: No ]
- Numbers of Fatal or Major Bleeding Complications [ Time Frame: upto 7 months after randomization ] [ Designated as safety issue: Yes ]
| Enrollment: | 457 |
| Study Start Date: | August 2005 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: cilostazol
cilostazol 100mg bid plus placebo of clopidogrel
|
Drug: Cilostazol
Cilostazol 100mg twice a day plus placebo of clopidogrel once a day
Other Name: cilostazol produced by Korea Otsuka Pharmaceutical
|
|
Active Comparator: Clopidogrel
clopidogrel 75mg qd and matching placebo of cilostazol
|
Drug: clopidogrel
Clopidogrel 75mg once a day plus placebo of cilostazol twice a day
Other Name: Plavix, produced by Sanofi-Aventis.
|
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
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
Locations
| Hong Kong | |
| Prince of Wales Hospital | |
| Hong Kong, Hong Kong | |
| Queen Mary Hospital | |
| Hong Kong, Hong Kong | |
| Korea, Republic of | |
| Konkuk Univ. Hospital | |
| Seoul, Gwangjin-gu Hwayang-dong, Korea, Republic of, 143-729 | |
| Inje University Ilsan Paik Hospital | |
| Goyang, Gyeonggi-do, Korea, Republic of, 411-706 | |
| Dongguk University International Hospital | |
| Goyang, Kyoungki-do, Korea, Republic of, 410-773 | |
| Hallym University Sacred Heart Hospital | |
| Anyang, Kyunggi, Korea, Republic of, 430-070 | |
| Inha University Hospital | |
| Inchon, Korea, Republic of, 400-103 | |
| Seoul National University Bundang Hospital | |
| Seongnam, Korea, Republic of | |
| Samsung Medical Center | |
| Seoul, Korea, Republic of, 135-710 | |
| Asan Medical Center | |
| Seoul, Korea, Republic of, 138-736 | |
| Eulji Hospital | |
| Seoul, Korea, Republic of, 280-1 | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of, 110-744 | |
| Kangdong Sacred Heart Hospital, Hallym University | |
| Seoul, Korea, Republic of, 134-701 | |
| Seoul National University Boramae Hospital | |
| Seoul, Korea, Republic of, 156-707 | |
| Soonchunhyang University Hospital | |
| Seoul, Korea, Republic of, 140-743 | |
| Philippines | |
| University of Santo Tomas Hospital | |
| Manila, Philippines | |
| Philippine General Hospital | |
| Manila, Philippines | |
| Thailand | |
| Siriraj Hospital | |
| Bangkok, Thailand | |
| Ramathibodi Hospital | |
| Bangkok, Thailand | |
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
No publications provided by Asan Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sun U. Kwon, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT00130039 History of Changes |
| Other Study ID Numbers: | TOSS-2 |
| Study First Received: | August 11, 2005 |
| Results First Received: | October 23, 2009 |
| Last Updated: | January 4, 2010 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Asan Medical Center:
|
Infarction, Cerebral cilostazol stenosis atherosclerosis clopidogrel |
Additional relevant MeSH terms:
|
Atherosclerosis Cerebral Infarction Stroke Constriction, Pathologic Infarction Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Pathological Conditions, Anatomical Ischemia Pathologic Processes Necrosis Cilostazol Ticlopidine Clopidogrel Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013