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

Information source: Jinling Hospital, China
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: CVD

Intervention: Argatroban (Drug); non-argatroban treated group (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Jinling Hospital, China

Official(s) and/or principal investigator(s):
Xinfeng Liu, MD, Study Chair, Affiliation: Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

Overall contact:
Xinfeng Liu, MD, Phone: (++) 86- (+) -25-84801861, Email: xfliu2@yahoo.com.cn

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.

Clinical Details

Official title: Phase 4 Study of Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: occlusion and restenosis

Secondary outcome:

NIHSS, mRS

Various adverse effects

clinical endpoints

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 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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Xinfeng Liu, MD, Phone: (++) 86- (+) -25-84801861, Email: xfliu2@yahoo.com.cn

Department of Neurology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu 210002, China; Recruiting
Xinfeng Liu, MD, Phone: (++) 86- (+) -25-84801861, Email: xfliu2@yahoo.com.cn
Xinfeng Liu, MD, Principal Investigator
Additional Information

Starting date: August 2010
Last updated: October 6, 2012

Page last updated: February 07, 2013

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