NCT01980316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

November 4, 2013

Last Update Submit

October 21, 2015

Conditions

CVD

Keywords

ArgatrobanExtracranial vertebral Artery Stentingrestenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • NIHSS, mRS

    at half a year

Other Outcomes (1)

  • Various adverse effects

    at half a year

Study Arms (2)

Argatroban group

EXPERIMENTAL

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: ArgatrobanDrug: non-argatroban treated group

non-argatroban treated group

EXPERIMENTAL

Patients in control group will receive Unfractionated heparin treatment

Drug: ArgatrobanDrug: non-argatroban treated group

Interventions

ArgatrobanDRUG

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 groupnon-argatroban treated group
non-argatroban treated groupDRUG

Patients in control group will receive Unfractionated heparin treatment

Also known as: Unfractionated heparin
Argatroban groupnon-argatroban treated group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Interventions

argatrobanHeparin

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Xinfeng Liu, MD

    Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Argatroban for Preventing Restenosis After Extracranial vertebral Artery Stenting

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 8, 2013

Study Start

April 1, 2010

Primary Completion

August 1, 2011

Study Completion

July 1, 2013

Last Updated

October 23, 2015

Record last verified: 2015-10

Locations

CN(1)