Overview

This trial is active, not recruiting.

Condition cvd
Treatments argatroban, non-argatroban treated group
Phase phase 4
Sponsor Jinling Hospital, China
Start date August 2010
End date December 2013
Trial size 140 participants
Trial identifier NCT01163604, JLH

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
argatroban Argartroban
Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment
(Experimental)
Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
non-argatroban treated group aspirin, clopidogrel
Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.

Primary Outcomes

Measure
occlusion and restenosis
time frame: at one year

Secondary Outcomes

Measure
NIHSS, mRS
time frame: at one year
Various adverse effects
time frame: at one year
clinical endpoints
time frame: at one year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Phase 4 Study of Argatroban for Preventing Occlusion and Restenosis After 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Jinling Hospital, China.