Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting (APORIAS)
This study is currently recruiting participants.
Verified October 2012 by Jinling Hospital, China
Sponsor:
Jinling Hospital, China
Information provided by (Responsible Party):
Xinfeng Liu, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT01163604
First received: June 28, 2010
Last updated: October 6, 2012
Last verified: October 2012
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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:
- occlusion and restenosis [ 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 ]
| Estimated Enrollment: | 140 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | December 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163604
Contacts
| Contact: Xinfeng Liu, MD | (++) 86- (+) -25-84801861 | xfliu2@yahoo.com.cn |
Locations
| China, Jiangsu | |
| Department of Neurology, Jinling Hospital, Nanjing University School of Medicine | Recruiting |
| Nanjing, Jiangsu, China, 210002 | |
| Contact: Xinfeng Liu, MD (++) 86- (+) -25-84801861 xfliu2@yahoo.com.cn | |
| Principal Investigator: Xinfeng Liu, MD | |
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 |
| Last Updated: | October 6, 2012 |
| 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:
|
Aspirin Argatroban Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents |
Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Anticoagulants Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists |
ClinicalTrials.gov processed this record on June 18, 2013