Status:
COMPLETED
Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Korea Otsuka International Asia Arab
Conditions:
Cerebral Infarction
Atherosclerosis
Eligibility:
All Genders
35+ years
Phase:
PHASE4
Brief 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...
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, Act...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
457 Patients enrolled
Trial Details
Trial ID
NCT00130039
Start Date
August 1 2005
End Date
January 1 2009
Last Update
January 12 2010
Active Locations (19)
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1
Prince of Wales Hospital
Hong Kong, Hong Kong
2
Queen Mary Hospital
Hong Kong, Hong Kong
3
Philippine General Hospital
Manila, Philippines
4
University of Santo Tomas Hospital
Manila, Philippines