Argatroban for Preventing Occlusion and Restenosis After Extracranial Vertebral Artery Stenting
- Registration Number
- NCT01980316
- Lead Sponsor
- Xinfeng Liu
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- For Extracranial vertebral Artery lesion, stenting was considered for symptomatic stenosis≥50% or asymptomatic stenosis≥70%;
- Successfully had intracranial or extracranial artery stenting.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description non-argatroban treated group non-argatroban treated group Patients in control group will receive Unfractionated heparin treatment Argatroban group non-argatroban treated 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 Argatroban group Argatroban 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 non-argatroban treated group Argatroban Patients in control group will receive Unfractionated heparin treatment
- Primary Outcome Measures
Name Time Method restenosis 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%
- Secondary Outcome Measures
Name Time Method NIHSS, mRS at half a year NIHSS and mRS are widely used stroke deficit assessment tools. Most clinical stroke-related trials require a baseline and outcome severity assessment. The baseline of mRS is rank 0, NIHSS 0; the severity of mRS is 6, NIHSS 42. AS many patients have one or more strokes before they perform stenting, this study selected NIHSS and mRS as the supplementary materials to estimate the stroke deficit of patients and to reflect the therapeutic effect and safety of stenting and argatroban therapy. These two scales are performed according to the guidance before and after stenting and argatroban therapy.
Trial Locations
- Locations (1)
Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
🇨🇳Nanjing, Jiangsu, China