Argatroban for Preventing Occlusion and Restenosis After Extracranial Vertebral Artery Stenting

Sponsor

Xinfeng Liu (Other)

Overall Status

Completed

CT.gov ID

NCT01980316

Collaborator

(none)

114

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
CVD	Drug: Argatroban Drug: non-argatroban treated group	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 4 Study of Argatroban for Preventing Restenosis After Extracranial Vertebral Artery Stenting

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: 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 Drug: non-argatroban treated group Patients in control group will receive Unfractionated heparin treatment Other Names: Unfractionated heparin
Experimental: non-argatroban treated group Patients in control group will receive Unfractionated heparin treatment	Drug: 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 Drug: non-argatroban treated group Patients in control group will receive Unfractionated heparin treatment Other Names: Unfractionated heparin

Arm

Intervention/Treatment

Experimental: 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

Drug: 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

Drug: non-argatroban treated group

Patients in control group will receive Unfractionated heparin treatment

Other Names:

Unfractionated heparin

Experimental: non-argatroban treated group

Patients in control group will receive Unfractionated heparin treatment

Drug: 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

Drug: non-argatroban treated group

Patients in control group will receive Unfractionated heparin treatment

Other Names:

Unfractionated heparin

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Various adverse effects [at half a year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

For Extracranial vertebral Artery lesion, stenting was considered for symptomatic stenosis≥50% or asymptomatic stenosis≥70%;
Successfully had intracranial or extracranial artery stenting.

Exclusion Criteria:

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