NCT01986192: 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

Status unknown NA Last updated 18 November 2014

What this trial tests

NA trial testing rivaroxaban in Ileofemoral Deep Vein Thrombosis in 72 participants. Status unknown.

Timeline

1 November 2013

Primary endpoint
1 February 2015

1 November 2015

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	1 November 2013
Primary completion	1 February 2015
Estimated completion	1 November 2015
Sites	1 location across South Korea

Drugs / interventions tested

• rivaroxaban (rivaroxaban) — full drug profile →
• Warfarin (warfarin) — full drug profile →

Conditions studied

• Ileofemoral Deep Vein Thrombosis — all drugs for Ileofemoral Deep Vein Thrombosis →

Sponsor

Seoul National University Hospital

Who can join

Adults 18 to 75, any sex, with Ileofemoral Deep Vein Thrombosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• recurrence rate
  Time frame: six month
  to compare recurrence rate within 6 months after thrombolysis in iliofemoral deep vein thrombosis with warfarin prophylaxis

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Rivaroxaban after Thrombolysis in Acute Iliofemoral Venous Thrombosis: A Randomized, Open-labeled, Multicenter Trial.
   Kang JM, Park KH, Ahn S, Cho S, et al · · 2019 · cited 16× · PMID 31889152 · DOI 10.1038/s41598-019-56887-w