Clinical trial NCT01986192: Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis (PRAIS) Study
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ileofemoral Deep Vein Thrombosis
Keywords: anticoagulation
pharmacomechanical thrombolysis
aspiration thrombectomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Daegu Catholic University Medical Center
name: Seoul National University Bundang Hospital
name: SMG-SNU Boramae Medical Center
name: The Catholic University of Korea
First posted: 2013-11-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: recurrence rate
timeFrame: six month
Secondary outcomes:
measure: vascular events
timeFrame: six months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seung-Kee Min, MD
role: PRINCIPAL_INVESTIGATOR
References: