Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis (PRAIS) Study (PRAIS)
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|ClinicalTrials.gov Identifier: NCT01986192|
Recruitment Status : Unknown
Verified November 2014 by Seung-Kee Min, Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : November 18, 2013
Last Update Posted : November 19, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Ileofemoral Deep Vein Thrombosis||Drug: rivaroxaban Drug: Warfarin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2013|
|Estimated Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||November 2015|
Rivaroxaban 15mg bid for 3 weeks and 20mg qd for 6 months
Other Name: xarelto
Active Comparator: warfarin
Enoxaparin 1mg/kg bid overlapping with warfarin (target PT INR 2.0-3.0) for 6 months
- recurrence rate [ Time Frame: six month ]to compare recurrence rate within 6 months after thrombolysis in iliofemoral deep vein thrombosis with warfarin prophylaxis
- vascular events [ Time Frame: six months ]All-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack or systemic embolism)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986192
|Contact: Seung-Kee Min, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110-744|
|Contact: Sang-il Min, MD 02-2072-2330 email@example.com|
|Principal Investigator:||Seung-Kee Min, MD||Seoul National University Hospital|