Clopidogrel Resistance and Embolism in Carotid Artery Stenting

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of the ticlopidine + ginko biloba compared to clopidogrel in clopidogrel resistant patients undergoing carotid artery stent placement. The investigators hypothesized that ticlopidine + ginko biloba is superior than clopidogrel in terms of post-stent ischemic lesions in these patients without serious complications.

Official Title
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Ticlopidine+Ginkgo Biloba Versus Clopidogrel in Clopidogrel Resistant Patients Undergoing Cartoid Artery Stent Placement

Conditions
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Carotid Stenosis

Intervention / Treatment
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* Drug: Ticlopidine + Ginko biloba
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for stent implantation due to carotid stenosis Patients resistant to clopidogrel defined by platelet inhibition rate <20% measured by Verify Now before carotid stenting Patients with informed consent Exclusion Criteria: Antiplatelet therapy other than aspirin, clopidogrel, or ticlopidine Unable to perform MRI scans Patients with hematologic abnormalities including neutrophil <1500/ul, platelet <100,000/uL, or AST/ALT >120 U/L Unsuitable for participation

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticlopidine+Ginko biloba<br>Switch to ticlopidine + ginko biloba | Drug: Ticlopidine + Ginko biloba<br>* ticlopidine hydrochloride 250mg, ginko leaf ext. 80mg, twice daily<br>* Other names: Yuclid;|
| Active Comparator: Clopidogrel<br>Keep clopidogrel | Drug: Clopidogrel<br>* clopidogrel bisulfate 97.875mg(75mg as clopidogrel)<br>* Other names: Plavix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New ischemic lesion on diffusion-weighted imaging (DWI) | Presence of new ischemic lesion in the ipsilesioinal hemisphere on DWI after carotid stening | within 24 hours after carotid stenting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Volume of new ischemic lesions on DWI |  | within 24 hours after carotid stenting | 
| Benign and malignant microembolic signals (MES) on transcranial Doppler (TCD) |  | within 24 hours after carotid stenting | 
| Ischemic stroke or transient ischemic attack (TIA) |  | within 30 days after carotid stenting | 
| Change of clopidogrel resistance | Change of clopidogrel resistance measured by Verify now (P2Y12) | 1 day after carotid stenting | 
| Pucture site hematoma |  | within 30 days after carotid stenting | 
| Mycocardial infarction |  | within 30 days after carotid stenting | 
| Death |  | within 30 days after carotid stenting | 
| Hematological abnormalities | Neutrophil <1500/uL Platelet <100,000/uL AST or ALT >120 U/L | within 30 days after carotid stenting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid stenosis, Stenting, Clopidogrel resistance, Stroke, ischemic