Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis (PRAIS) Study (NCT01986192) | Clinical Trial Compass
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Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis (PRAIS) Study
South Korea72 participantsStarted 2013-11
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.