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Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting

NCT ID: NCT01163604

Last Updated: 2015-11-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-08-31

Brief Summary

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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 restenosis post cranial stenting. This study will test the safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with intracranial and extracranial artery stenting.

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 restenosis post cranial stenting. This study will test the safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with intracranial and extracranial 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

Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.

Group Type EXPERIMENTAL

Argatroban

Intervention Type DRUG

Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment

non-argatroban treated group

Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.

Group Type EXPERIMENTAL

non-argatroban treated group

Intervention Type DRUG

Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.

Interventions

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Argatroban

Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment

Intervention Type DRUG

non-argatroban treated group

Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.

Intervention Type DRUG

Other Intervention Names

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Argartroban aspirin, clopidogrel

Eligibility Criteria

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Inclusion Criteria

* For extracranial artery lesion, stenting was considered for symptomatic stenosis≥50% or asymptomatic stenosis≥70%; according to intracranial artery lesion, stenting was considered for symptomatic stenosis≥70% in invalid patients after intensive medical therapy.
* 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 intracranial and extracranial artery stenting
* Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc.
* Serum creatinine \>1.5 mg/dL
* Hypersensitivity to test drugs
* Difficult to hand follow-up visit
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Xinfeng Liu

Jinling Hospital, China

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xinfeng Liu, MD

Role: STUDY_CHAIR

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

Locations

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

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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JLH

Identifier Type: -

Identifier Source: org_study_id