Ileofemoral Deep Vein ThrombosisPRAISNCT01986192
Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis (PRAIS) Study
A study testing rivaroxaban and Warfarin in people with Ileofemoral Deep Vein Thrombosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ileofemoral Deep Vein Thrombosis
- What is being tested?
- rivaroxaban and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Sang-il Min, MD, 02-2072-2330, surgeonmsi@gmail.com
About this 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
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.
Read more
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.
- Conditions
- Ileofemoral Deep Vein Thrombosis
- Being tested
- rivaroxaban, Warfarin
- Keywords
- anticoagulation, pharmacomechanical thrombolysis, aspiration thrombectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rivaroxabanDrug
Also called xarelto
WarfarinDrug
| Study group | Role | What they receive |
|---|---|---|
| rivaroxaban | Experimental | Rivaroxaban 15mg bid for 3 weeks and 20mg qd for 6 months Receives: Drug: rivaroxaban |
| warfarin | Active comparator | Enoxaparin 1mg/kg bid overlapping with warfarin (target PT INR 2.0-3.0) for 6 months Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
to compare recurrence rate within 6 months after thrombolysis in iliofemoral deep vein thrombosis with warfarin prophylaxis
Measured: six month
Secondary outcomes (1)
vascular events
All-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack or systemic embolism)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileofemoral Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daegu Catholic University Medical Center, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, The Catholic University of Korea
- Responsible party
- Principal investigator, Seung-Kee Min, Seoul National University Hospital
- Investigators
- Seung-Kee Min, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986192
- Sponsor's protocol ID
- PRAIS-1.1-12-12
- Acronym
- PRAIS
- Status last verified
- Nov 2014
- First submitted
- 11 Nov 2013
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01986192
- Acronym / sponsor ID
- PRAIS / PRAIS-1.1-12-12
- Conditions
- Ileofemoral Deep Vein Thrombosis
- Keywords
- anticoagulation, pharmacomechanical thrombolysis, aspiration thrombectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Daegu Catholic University Medical Center, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, The Catholic University of Korea
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rivaroxaban | Experimental | Drug: rivaroxabanRivaroxaban 15mg bid for 3 weeks and 20mg qd for 6 months |
| warfarin | Active comparator | Drug: WarfarinEnoxaparin 1mg/kg bid overlapping with warfarin (target PT INR 2.0-3.0) for 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rivaroxabanAlso: xarelto | Drug | rivaroxaban |
| Warfarin | Drug | warfarin |
Primary outcome
recurrence rate
Time frame: six month
to compare recurrence rate within 6 months after thrombolysis in iliofemoral deep vein thrombosis with warfarin prophylaxis
1 secondary outcome
vascular events
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
Related trials for Ileofemoral Deep Vein Thrombosis
Recruiting
PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis
Deep Vein Thrombosis
Active, not recruitingObservational study
Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System
Acute Deep Venous Thrombosis of Ileofemoral Vein
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Kee Min, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rivaroxaban and Warfarin in people with Ileofemoral Deep Vein Thrombosis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung-Kee Min, MD (02-2072-0297, skminmd@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate (time frame: six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.