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

NCT01163604 | Completed Phase 4 Results DMC

• 1 other identifier: JLH
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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

CVD

Keywords

Argatroban; intracranial artery stenting; extracranial artery stenting; occlusion; restenosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Occlusion and Restenosis at One Year

  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 one year

Secondary Outcomes (3)

• NIHSS, mRS

  at one year

• Various Adverse Effects

  at one year

• Clinical Endpoints

  at one year

Study Arms (2)

Argatroban group

EXPERIMENTAL

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.

Drug: Argatroban

non-argatroban treated group

EXPERIMENTAL

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

Drug: non-argatroban treated group

Interventions

Argatroban 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

Also known as: Argartroban

Argatroban group

non-argatroban treated group DRUG

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

Also known as: aspirin, clopidogrel

non-argatroban treated group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Bites and Stings

Interventions

argatroban; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: xinfeng Liu
• Organization: jinling hospital

xfliu2@vip.163.com

025-84801861

Study Officials

• Xinfeng Liu, MD

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jinling Hospital, China

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: July 16, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: August 1, 2014
• Last Updated: November 23, 2015
• Results First Posted: November 7, 2014

Record last verified: 2015-10

Locations

CN (1)