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

Information source: Jinling Hospital, China
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: CVD

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

Phase: Phase 4

Status: Completed

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

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: Number of Participants With Occlusion and Restenosis at One Year

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

Department of Neurology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu 210002, China
Additional Information

Starting date: August 2010
Last updated: October 31, 2014

Page last updated: August 20, 2015

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