Clinical trial NCT01163604: Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting
Official title: Phase 4 Study of Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: CVD
Keywords: Argatroban
intracranial artery stenting
extracranial artery stenting
occlusion
restenosis
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2010-07-16
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Number of Participants With Occlusion and Restenosis at One Year
timeFrame: at one year
Secondary outcomes:
measure: NIHSS, mRS
timeFrame: at one year
measure: Various Adverse Effects
timeFrame: at one year
measure: Clinical Endpoints
timeFrame: at one year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
state: Jiangsu
Study officials:
affiliation: Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
name: Xinfeng Liu, MD
role: STUDY_CHAIR
References: