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

Seoul National University

Status: Unknown

Conditions: Ileofemoral Deep Vein Thrombosis

Treatments: Drug: Warfarin; Drug: rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT01986192

PRAIS-1.1-12-12

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

rivaroxaban

Experimental group

Description:

Rivaroxaban 15mg bid for 3 weeks and 20mg qd for 6 months

Treatment:

Drug: rivaroxaban

warfarin

Active Comparator group

Description:

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

Treatment:

Drug: Warfarin