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

NCT01986192 | Unknown

• 1 other identifier: PRAIS-1.1-12-12
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileofemoral Deep Vein Thrombosis

Keywords

anticoagulation; pharmacomechanical thrombolysis; aspiration thrombectomy

Outcome Measures

Primary Outcomes (1)

• recurrence rate

  to compare recurrence rate within 6 months after thrombolysis in iliofemoral deep vein thrombosis with warfarin prophylaxis

  six month

Secondary Outcomes (1)

• vascular events

  six months

Study Arms (2)

rivaroxaban

EXPERIMENTAL

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

Drug: rivaroxaban

warfarin

ACTIVE COMPARATOR

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

Drug: Warfarin

Interventions

rivaroxaban DRUG

Also known as: xarelto

rivaroxaban

Warfarin DRUG

warfarin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Daegu Catholic University Medical Center: collaborator
• Seoul National University Bundang Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator
• The Catholic University of Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Interventions

Rivaroxaban; Warfarin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Seung-Kee Min, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Kee Min, MD

CONTACT

02-2072-0297; skminmd@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: November 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

KR (1)