Ileofemoral Deep Vein Thrombosis Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment