Phase 4 Study of Argatroban for Preventing Restenosis After Extracranial Vertebral Artery Stenting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- restenosis
研究概览
简要总结
Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post percutaneous coronary intervention could potentially prevent reocclusion. But there has no study on large sample of argatroban treated restenosis vertebral artery stenting. This study will test the safety and efficacy of the argatroban on prevent Occlusion and Restenosis in patients with Extracranial vertebral Artery Stenting.
详细描述
The risk of restenosis post intracranial and extracranial artery stenting is 20-40%, therefore, in the past, aspirin and clopidogrel were performed as anticoagulant therapy post stenting.But this treatment had limited effectiveness upon restenosis. Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post PCI could potentially prevent reocclusion. But there has no study on large sample of argatroban treated Occlusion and Restenosis Extracranial vertebral Artery Stenting. This study will test the safety and efficacy of the argatroban on prevent Occlusion and Restenosis in patients with Extracranial vertebral Artery Stenting.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Extracranial vertebral Artery lesion, stenting was considered for symptomatic stenosis≥50% or asymptomatic stenosis≥70%;
- •Successfully had intracranial or extracranial artery stenting.
排除标准
- •Evidence of hemorrhagic brain infarction, intracranial and extracranial hematoma, or intraventricular hemorrhage, or Gastrointestinal ulcers in 3 months
- •Hypersensitivity to contrast agent
- •Malignant hypertension
- •Difficult to perform the vertebral artery stenting
- •Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc.
- •Difficult to hand follow-up visit
研究组 & 干预措施
Argatroban group
Argatroban in patients undergoing load 250μg/kg, followed by 15μg/kg/min continuous intravenous infusion.5 days after surgery, take 10mg intravenous infusion of speed 2/day
干预措施: Argatroban (Drug)
Argatroban group
Argatroban in patients undergoing load 250μg/kg, followed by 15μg/kg/min continuous intravenous infusion.5 days after surgery, take 10mg intravenous infusion of speed 2/day
干预措施: non-argatroban treated group (Drug)
non-argatroban treated group
Patients in control group will receive Unfractionated heparin treatment
干预措施: Argatroban (Drug)
non-argatroban treated group
Patients in control group will receive Unfractionated heparin treatment
干预措施: non-argatroban treated group (Drug)
结局指标
主要结局
restenosis
时间窗: at half a year
Stenosis detected by DSA(digital subtraction angiography),CTA(CT angiography)or MRA(MR angiography)was measured according to NASCET(North American Symptomatic Carotid Endarterectomy Trial)method.Concretely, NASCET stenosis is calculated from the ratio of the linear luminal diameter of the narrowest segment of the diseased portion of the artery to the diameter of the artery beyond any poststenotic dilatation: NASCET=(1-md/C)×100%
次要结局
- NIHSS, mRS(at half a year)
研究者
Xinfeng Liu
Argatroban for Preventing Restenosis After Extracranial vertebral Artery Stenting
Jinling Hospital, China