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Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis (PRAIS) Study (PRAIS)

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ClinicalTrials.gov Identifier: NCT01986192
Recruitment Status : Unknown
Verified November 2014 by Seung-Kee Min, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : November 18, 2013
Last Update Posted : November 19, 2014
Sponsor:
Collaborators:
Daegu Catholic University Medical Center
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center
The Catholic University of Korea
Information provided by (Responsible Party):
Seung-Kee Min, Seoul National University Hospital

Brief Summary:

The EINSTEIN program showed that oral rivaroxaban is effective and safe treatment for prevention of recurrent venous thrombosis and pulmonary embolism in deep vein thrombosis patients and FDA approved the rivaroxaban for prevention and treatment of deep vein thrombosis (Nov 2 2012).

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.


Condition or disease Intervention/treatment Phase
Ileofemoral Deep Vein Thrombosis Drug: rivaroxaban Drug: Warfarin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Efficacy and Safety Study of Ribaroxaban for the Prevention of Deep Vein Thrombosis Recurrence in Patients With Acute Iliofemoral Venous Thrombosis Initially Treated With Thrombolysis
Study Start Date : November 2013
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rivaroxaban
Rivaroxaban 15mg bid for 3 weeks and 20mg qd for 6 months
Drug: rivaroxaban
Other Name: xarelto

Active Comparator: warfarin
Enoxaparin 1mg/kg bid overlapping with warfarin (target PT INR 2.0-3.0) for 6 months
Drug: Warfarin



Primary Outcome Measures :
  1. recurrence rate [ Time Frame: six month ]
    to compare recurrence rate within 6 months after thrombolysis in iliofemoral deep vein thrombosis with warfarin prophylaxis


Secondary Outcome Measures :
  1. vascular events [ Time Frame: six months ]
    All-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack or systemic embolism)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-75 years
  • 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:

  • Incomplete catheter-directed thrombolysis
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986192


Contacts
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Contact: Seung-Kee Min, MD 02-2072-0297 skminmd@yahoo.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Sang-il Min, MD    02-2072-2330    surgeonmsi@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Daegu Catholic University Medical Center
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center
The Catholic University of Korea
Investigators
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Principal Investigator: Seung-Kee Min, MD Seoul National University Hospital
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Responsible Party: Seung-Kee Min, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01986192    
Other Study ID Numbers: PRAIS-1.1-12-12
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014
Keywords provided by Seung-Kee Min, Seoul National University Hospital:
anticoagulation
pharmacomechanical thrombolysis
aspiration thrombectomy
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Recurrence
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Warfarin
Rivaroxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action