Phase 4 Study of Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial 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
- Number of Participants With Occlusion and Restenosis at One Year
研究概览
简要总结
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 restenosis post cranial stenting. This study will test the safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with intracranial and extracranial 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 restenosis post cranial stenting. This study will test the safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with intracranial and extracranial 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 artery lesion, stenting was considered for symptomatic stenosis≥50% or asymptomatic stenosis≥70%; according to intracranial artery lesion, stenting was considered for symptomatic stenosis≥70% in invalid patients after intensive medical therapy.
- •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 intracranial and extracranial artery stenting
- •Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc.
- •Serum creatinine >1.5 mg/dL
- •Hypersensitivity to test drugs
- •Difficult to hand follow-up visit
研究组 & 干预措施
Argatroban group
Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.
干预措施: Argatroban (Drug)
non-argatroban treated group
Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
干预措施: non-argatroban treated group (Drug)
结局指标
主要结局
Number of Participants With Occlusion and Restenosis at One Year
时间窗: at one 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
- Various Adverse Effects(at one year)
- Clinical Endpoints(at one year)
- NIHSS, mRS(at one year)
研究者
Xinfeng Liu
Jinling Hospital, China
Jinling Hospital, China