Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting
Information source: Jinling Hospital, China
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: CVD
Intervention: Argatroban (Drug); non-argatroban treated group (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Jinling Hospital, China Official(s) and/or principal investigator(s): Xinfeng Liu, MD, Study Chair, Affiliation: Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
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.
Clinical Details
Official title: Phase 4 Study of Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants With Occlusion and Restenosis at One Year
Secondary outcome: NIHSS, mRSVarious Adverse Effects Clinical Endpoints
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Department of Neurology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu 210002, China
Additional Information
Starting date: August 2010
Last updated: October 31, 2014
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