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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ileofemoral Deep Vein Thrombosis

Intervention / Treatment
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* Drug: rivaroxaban
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rivaroxaban<br>Rivaroxaban 15mg bid for 3 weeks and 20mg qd for 6 months | Drug: rivaroxaban<br> <br> * Other names: xarelto;|
| Active Comparator: warfarin<br>Enoxaparin 1mg/kg bid overlapping with warfarin (target PT INR 2.0-3.0) for 6 months | Drug: Warfarin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate | to compare recurrence rate within 6 months after thrombolysis in iliofemoral deep vein thrombosis with warfarin prophylaxis | six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular events | All-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack or systemic embolism) | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticoagulation, pharmacomechanical thrombolysis, aspiration thrombectomy