Status:
COMPLETED
Effect of Cilostazol in the Acute Lacunar Infarction Based on Pulsatility Index of Transcranial Doppler
Lead Sponsor:
Inje University
Collaborating Sponsors:
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Cerebral Infarction
Eligibility:
All Genders
45+ years
Phase:
PHASE4
Brief Summary
RATIONALE: * Elevation in pulsatility indices (PIs), measured by transcranial Doppler (TCD), has been postulated to reflect downstream increased vascular resistance caused by small-vessel disease (SV...
Detailed Description
TREATMENTS: * Cilostazol is an agent inhibiting platelet aggregation. * A matching placebo of cilostazol is an inactive substance that looks similar to the active cilostazol tablet. TREATMENT PLAN: ...
Eligibility Criteria
Inclusion
- Patients with first ever lacunar infarction within 7 days after the onset of symptoms
- Age: more than 45 years of age
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)
- 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.
- Pregnant or lactating patients
- Patients with hyperthyroidism or COPD
- Patients with current anticoagulation or antiplatelet therapy
- Patients with poor temporal window in transcranial Doppler
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00741286
Start Date
November 1 2006
End Date
October 1 2008
Last Update
September 5 2011
Active Locations (8)
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1
Sanbon Medical Center
Gunpo, South Korea, 435-040
2
National Health Insurance Corporation Ilsan Hospital
Ilsan, South Korea, 411-719
3
Bundang CHA Hospital
Seongnam, South Korea, 463-712
4
National medical center
Seoul, South Korea, 100-799