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

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

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.

Study Overview

• Status: Unknown
• Conditions: Ileofemoral Deep Vein Thrombosis
• Intervention / Treatment: Drug: Warfarin; Drug: rivaroxaban

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital
    • Contact: Sang-il Min, MD; Phone Number: 02-2072-2330; Email: surgeonmsi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital; Daegu Catholic University Medical Center; SMG-SNU Boramae Medical Center; The Catholic University of Korea
• Investigators: Principal Investigator: Seung-Kee Min, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: November 15, 2013
• First Posted (Estimate): November 18, 2013

Study Record Updates

• Last Update Posted (Estimate): November 19, 2014
• Last Update Submitted That Met QC Criteria: November 18, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: anticoagulation; pharmacomechanical thrombolysis; aspiration thrombectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Embolism and Thrombosis; Recurrence; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Warfarin
• Other Study ID Numbers: PRAIS-1.1-12-12