Argatroban for Preventing Occlusion and Restenosis After Extracranial Vertebral Artery Stenting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-07-31

Brief Summary

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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.

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Coronary Artery Disease

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Detailed Description

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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.

Conditions

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CVD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Argatroban

Intervention Type DRUG

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

Intervention Type DRUG

Patients in control group will receive Unfractionated heparin treatment

non-argatroban treated group

Patients in control group will receive Unfractionated heparin treatment

Group Type EXPERIMENTAL

Argatroban

Intervention Type DRUG

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

Intervention Type DRUG

Patients in control group will receive Unfractionated heparin treatment

Interventions

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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

Intervention Type DRUG

non-argatroban treated group

Patients in control group will receive Unfractionated heparin treatment

Intervention Type DRUG

Other Intervention Names

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Unfractionated heparin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No