Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting (APORIAS)

Jinling Hospital, China

Status and phase: Completed; Phase 4

Conditions: CVD

Treatments: Drug: non-argatroban treated group; Drug: Argatroban

Study type: Interventional

Funder types: Other

Identifiers

NCT01163604

JLH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Argatroban group

Experimental group

Description:

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.

Treatment:

Drug: Argatroban

non-argatroban treated group

Experimental group

Description:

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

Treatment:

Drug: non-argatroban treated group