Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis (PRAIS) Study
NCT ID: NCT01986192
Last Updated: 2014-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
72 participants
INTERVENTIONAL
2013-11-30
2015-11-30
Brief Summary
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Recently, catheter-directed thrombolysis can significantly reduce post-thrombotic syndrome, and more and more centers introduce catheter-directed thrombolysis to treat proximal (i.e, iliofemoral) DVT. However, the EINSTEIN program excluded patients with deep vein thrombosis if they had been treated with a vena cava filter or a fibrinolytic agent for the current episode of thrombosis.
Although catheter-directed thrombolysis (CDT) or pharmacomechanical thrombolysis has now been accepted as a treatment of choice in iliofemoral DVT, thrombolysis has an inherent risk of bleeding. Therefore, patients who have completed CDT and have been stabilized at least 24 hours after thrombolysis will be included in this study.
Also, the investigators want to explore the efficacy and safety of rivaroxaban in patients with iliofemoral DVT after catheter-directed thrombolysis and/or a vena cava filter insertion and/or venous stent insertion and compare these outcomes with warfarin treatment alone.
This study will be a pilot study to establish the safety and efficacy parameters for further studies.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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rivaroxaban
Rivaroxaban 15mg bid for 3 weeks and 20mg qd for 6 months
rivaroxaban
warfarin
Enoxaparin 1mg/kg bid overlapping with warfarin (target PT INR 2.0-3.0) for 6 months
Warfarin
Interventions
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rivaroxaban
Warfarin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Onset of symptoms within the past 21 days
* Objectively verified (by CT venography) deep vein thrombosis localized in the iliofemoral segment
* Complete catheter-directed thrombolysis and/or a vena cava and/or venous stent insertion
* Informed consent
Exclusion Criteria
* If patients received more than a single dose of a warfarin before randomization
* contraindicating anticoagulant treatment
* another indication for a warfarin
* an estimated glomerular filtration rate by MDRD equation \<30ml/min
* clinically significant liver disease (acute hepatitis, chronic active hepatitis, cirrhosis)
* Alanine aminotransferase \> 3-time higher than upper limit of the normal range
* Bacterial endocarditis
* Active bleeding or high risk of bleeding
* Pregnancy or breast-feeding
* Concomitant use of strong cytochrome P-450 3A4 inhibitors or inducers
18 Years
75 Years
ALL
No
Sponsors
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Daegu Catholic University Medical Center
OTHER
Seoul National University Bundang Hospital
OTHER
SMG-SNU Boramae Medical Center
OTHER
The Catholic University of Korea
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Seung-Kee Min
Professor
Principal Investigators
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Seung-Kee Min, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PRAIS-1.1-12-12
Identifier Type: -
Identifier Source: org_study_id