Ileofemoral Deep Vein Thrombosis Clinical Trial
— PRAISOfficial 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.
| Status | Recruiting |
| Enrollment | 72 |
| Est. completion date | November 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital | Daegu Catholic University Medical Center, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, The Catholic University of Korea |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | recurrence rate | to compare recurrence rate within 6 months after thrombolysis in iliofemoral deep vein thrombosis with warfarin prophylaxis | six month | No |
| Secondary | vascular events | All-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack or systemic embolism) | six months | No |