Argatroban for Preventing Occlusion and Restenosis After Extracranial Vertebral Artery Stenting

Xinfeng Liu

Status and phase: Completed; Phase 4

Conditions: CVD

Treatments: Drug: non-argatroban treated group; Drug: Argatroban

Study type: Interventional

Funder types: Other

Identifiers

NCT01980316

JLH3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Argatroban group

Experimental group

Description:

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

Treatment:

Drug: Argatroban

Drug: non-argatroban treated group

non-argatroban treated group

Experimental group

Description:

Patients in control group will receive Unfractionated heparin treatment

Treatment:

Drug: Argatroban

Drug: non-argatroban treated group