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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xinfeng Liu, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT01163604
First received: June 28, 2010
Last updated: October 31, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
CVD
Drug: Argatroban
Drug: non-argatroban treated group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting

Resource links provided by NLM:


Further study details as provided by Jinling Hospital, China:

Primary Outcome Measures:
  • Number of Participants With Occlusion and Restenosis at One Year [ Time Frame: at one year ] [ Designated as safety issue: Yes ]
    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%


Secondary Outcome Measures:
  • NIHSS, mRS [ Time Frame: at one year ] [ Designated as safety issue: Yes ]
    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.

  • Various Adverse Effects [ Time Frame: at one year ] [ Designated as safety issue: Yes ]
  • Clinical Endpoints [ Time Frame: at one year ] [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: August 2010
Study Completion Date: August 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Argatroban group
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.
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
Other Name: Argartroban
Experimental: non-argatroban treated group
Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
Drug: non-argatroban treated group
Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
Other Name: aspirin, clopidogrel

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163604

Locations
China, Jiangsu
Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Jinling Hospital, China
Investigators
Study Chair: Xinfeng Liu, MD Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
  More Information

No publications provided

Responsible Party: Xinfeng Liu, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01163604     History of Changes
Other Study ID Numbers: JLH
Study First Received: June 28, 2010
Results First Received: October 25, 2014
Last Updated: October 31, 2014
Health Authority: China: Ministry of Health

Keywords provided by Jinling Hospital, China:
Argatroban
intracranial artery stenting
extracranial artery stenting
occlusion
restenosis

Additional relevant MeSH terms:
Argatroban
Aspirin
Clopidogrel
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticoagulants
Antipyretics
Antirheumatic Agents
Antithrombins
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protease Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Sensory System Agents

ClinicalTrials.gov processed this record on November 20, 2014