NCT02133989Unknown3 期
Ticlopidine+Ginkgo Biloba Versus Clopidogrel in Clopidogrel Resistant Patients Undergoing Cartoid Artery Stent Placement
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- New ischemic lesion on diffusion-weighted imaging (DWI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ticlopidine+Ginko biloba
Experimental
Switch to ticlopidine + ginko biloba
干预措施: Ticlopidine + Ginko biloba (Drug)
Clopidogrel
Active Comparator
Keep clopidogrel
干预措施: Clopidogrel (Drug)
结局指标
主要结局
New ischemic lesion on diffusion-weighted imaging (DWI)
时间窗: within 24 hours after carotid stenting
Presence of new ischemic lesion in the ipsilesioinal hemisphere on DWI after carotid stening
次要结局
- 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(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(within 30 days after carotid stenting)
研究者
Oh Young Bang
MD
Samsung Medical Center
研究点 (1)
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