NCT01163604

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• CVD

Interventions

Type	Name	Description
DRUG	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
DRUG	non-argatroban treated group	Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-12-01
• Completion: 2014-08-01
• First posted: 2010-07-16
• Last updated: 2015-11-23
• Results posted: 2014-11-07

Locations

1 site across 1 country: China