Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis (PRAIS) Study
- Conditions
- Ileofemoral Deep Vein Thrombosis
- Interventions
- Registration Number
- NCT01986192
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 72
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description warfarin Warfarin Enoxaparin 1mg/kg bid overlapping with warfarin (target PT INR 2.0-3.0) for 6 months rivaroxaban rivaroxaban Rivaroxaban 15mg bid for 3 weeks and 20mg qd for 6 months
- Primary Outcome Measures
Name Time Method recurrence rate six month to compare recurrence rate within 6 months after thrombolysis in iliofemoral deep vein thrombosis with warfarin prophylaxis
- Secondary Outcome Measures
Name Time Method vascular events six months All-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack or systemic embolism)
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of