Argatroban for Preventing Occlusion and Restenosis After Extracranial Vertebral Artery Stenting

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

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.

Study Overview

• Status: Completed
• Conditions: CVD
• Intervention / Treatment: Drug: Argatroban; Drug: non-argatroban treated group

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 Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
restenosis	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%	at half a year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS, mRS	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.	at half a year

Other Outcome Measures

Outcome Measure	Time Frame
Various adverse effects	at half a year

Collaborators and Investigators

• Sponsor: Xinfeng Liu

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: November 4, 2013
• First Submitted That Met QC Criteria: November 4, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Estimate): October 23, 2015
• Last Update Submitted That Met QC Criteria: October 21, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: restenosis; Argatroban; Extracranial vertebral Artery Stenting
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Calcium heparin; Argatroban
• Other Study ID Numbers: JLH3