Carotid Stenosis
Conditions
Keywords
Carotid stenosis, Stenting, Clopidogrel resistance, Stroke, ischemic
Brief summary
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.
Interventions
DRUGTiclopidine + Ginko biloba
ticlopidine hydrochloride 250mg, ginko leaf ext. 80mg, twice daily
DRUGClopidogrel
clopidogrel bisulfate 97.875mg(75mg as clopidogrel)
Sponsors
Yuyu Pharma, Inc.
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New ischemic lesion on diffusion-weighted imaging (DWI) | within 24 hours after carotid stenting | Presence of new ischemic lesion in the ipsilesioinal hemisphere on DWI after carotid stening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 day after carotid stenting | Change of clopidogrel resistance measured by Verify now (P2Y12) |
| Number and Volume of new ischemic lesions on DWI | within 24 hours after carotid stenting | — |
| Mycocardial infarction | within 30 days after carotid stenting | — |
| Death | within 30 days after carotid stenting | — |
| Hematological abnormalities | within 30 days after carotid stenting | Neutrophil \<1500/uL Platelet \<100,000/uL AST or ALT \>120 U/L |
| Pucture site hematoma | within 30 days after carotid stenting | — |
Countries
South Korea
Contacts
Primary ContactOh Young Bang, MD
Backup ContactSuk Jae Kim, MD
Outcome results
None listed