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

CVD Clinical Trial

— APORIAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163604
• Other study ID #: JLH
• Status: Completed
• Phase: Phase 4
• First received: June 28, 2010
• Last updated: October 21, 2015
• Start date: August 2010
• Est. completion date: August 2014

Study information

• Verified date: October 2015
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• CVD

Intervention

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

Locations

Country	Name	City	State
China	Department of Neurology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Occlusion and Restenosis at One Year	Stenosis detected by DSA(digital subtraction angiography),CTA(CT angiography)or MRA(MR angiography)was measured according to NASCET(North American Symptomatic Carotid Endarterectomy Trial)method.Concretely, NASCET stenosis is calculated from the ratio of the linear luminal diameter of the narrowest segment of the diseased portion of the artery to the diameter of the artery beyond any poststenotic dilatation: NASCET=(1-md/C)×100%	at one year	Yes
Secondary	NIHSS, mRS	NIHSS and mRS are widely used stroke deficit assessment tools. Most clinical stroke-related trials require a baseline and outcome severity assessment. The baseline of mRS is rank 0, NIHSS 0; the severity of mRS is 6, NIHSS 42. AS many patients have one or more strokes before they perform stenting, this study selected NIHSS and mRS as the supplementary materials to estimate the stroke deficit of patients and to reflect the therapeutic effect and safety of stenting and argatroban therapy. These two scales are performed according to the guidance before and after stenting and argatroban therapy.	at one year	Yes
Secondary	Various Adverse Effects		at one year	Yes
Secondary	Clinical Endpoints		at one year	Yes