Back to resultsXarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis. (RIPORT)
Primary Purpose
Deep Vein Thrombosis, Chronic Portal Vein Thrombosis
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Xarelto
Sponsored by
About this trial
This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring thrombosis
Eligibility Criteria
Inclusion Criteria:
- adult patients aged 18 to 90 years old
Patients either with :
- Portal cavernoma radiologically confirmed, treated or not by anticoagulant
- previous history of acute portal thrombosis for more than 6 months confirmed by angio-TDM or angio-MRI, repermeabilized or not
- prophylaxis of gastro-intestinal bleeding due to portal hypertension, as recommended for cirrhosis patients. Upper gastro-intestinal endoscopy for less than 12 months
- clinical examination
- for women of childbearing age, contraception, either mecanichal or intra-uterin device, or oral progestative alone. No oral oestroprogestative contraception is allowed.
- written informed consent
- covered by a social security scheme or French "CMU"
Exclusion Criteria:
- At least one High risk factors of thrombosis recurrence after review by the committee composed of an hepatologist and an hematologist specialist of hemostasis
- Cirrhosis clinically or histologically confirmed or Budd-Chiari syndrome
- Any disease leading to significant coagulopathy and clinically significant bleeding risk (platelets <50 000, or PT <30% without VKA, or Factor V <30% or Fibrinogen <0,8).
- Personal or familial (1rst degree) history of spontanaeous deep vein thrombosis requiring anticoagulant treatment
- pregnant or breast-feeding women
- History of mesenteric veinous ischemia leading to intestinal resection
- patient infected by HIV and treated by anti-protease
- Formal indication to anticoagulant treatment for any reason
- No possible follow-up
- severe renal injury (creatinin clearance <30 ml/min)
- Patients receiving a systemic treatment by azoled antifongic agent (such as ketoconazole, itraconazole, voriconazole or posaconazole), or a protease inhibitor. These are strong CYP3A4 and P-gp inhibitors.
- Patients receiving a systemic treatment by rifampicyn or any other strong CYP3A4 inducting/stimulator (phenytoïne, carbamazepine, phenobarbital or millepertuis/Hypericum perforatum)
- Hypersensitvity to rivaroxaban or excipients
- active bleeding, or any condition at risk for significant major bleeding
- Any other concomitant anticoagulant treatment, such as non-fractionnaed heparin, low-molecular weight heparin (enoxaparin, dalteparine, etc…), heparin derivatives (fondaparinux, etc), oral anticoagulant (warfarine, dabigatran etexilate, apixaban, etc) except in case of switch to Xarelto® or, in case of non-fractionnaed heparin administered to maintain central veinous or arterial catheterism permeability
- Concomitant treatment by clopidogrel / Plavix® for acute coronary syndrome
- hepatic transplantation
- Intra-hepatic shunt
Sites / Locations
- Hôpital Beaujon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Xarelto
untreated
Arm Description
15mg/day oral administration during 2 to 4 years (based on the recruitment date).
the patient won't receive any treatment during his study participation.
Outcomes
Primary Outcome Measures
Incidence of thromboembolic event in any territory ( splanchnic or extra splanchnic, lower limbs, cerebral veinous thrombosis, pulmonary embolism) or death
In patients with chronic portal vein thrombosis without high risk thrombophilia, to assess the efficacy of Xarelto in the recurrence of thromboembolic event compared to absence of treatment.
Secondary Outcome Measures
Efficacy of xarelto
Assess the efficacy regarding:
- Incidence of Pulmonary embolism, Deep vein thrombosis, Major bleedings and Portal hypertension bleeding, new non bleeding complication of portal hypertension, minor bleeding,
Safety of xarelto
Assess the safety regarding:
Toxicity of Xarelto, especially hepatic.
Gastrointestinal clinically relevant non major bleedings related to portal hypertension
Other gastrointestinal clinically relevant non major bleedings
Other adverse events
Survival (12months, 24 months and at the end of the follow up).
Number of hospitalization during follow up.
Evaluation of clotting activator marker with and without Xarelto.
Duration of hospitalization during follow up.
Full Information
NCT ID
NCT02555111
First Posted
August 28, 2015
Last Updated
July 22, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02555111
Brief Title
Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.
Acronym
RIPORT
Official Title
Multicentric Randomized Study of Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Open randomized therapeutic study to assess the efficacy of Xarelto 15mg/day in the recurrence of thromboembolic event compared to an untreated group in patients with chronic portal vein thrombosis without high risk thrombophilia.
Detailed Description
Chronic portal vein thrombosis (PVT) is a rare disease, affecting young patients, characterized by permanent obstruction of the portal vein trunk causing portal hypertension. In 60-70% of cases it is related to high risk, moderate or mild prothrombotic risk factors.
Accordingly, there are 2 types of complications from PVT :(i) gastrointestinal haemorrhage related to portal hypertension; and (ii) recurrent thrombosis.
Recurrent thrombosis its most dreaded complication as it may lead to intestinal infarction with a related mortality of 20-60% and a high risk of intestinal insufficiency.
Gastrointestinal haemorrhage related to portal hypertension occurs in 20% patients/year. It is less frequent in patients treated with medical or endoscopic prophylaxis for variceal bleeding.
Retrospective data shows that anticoagulation does not worsen the prognosis, and may conversely improve it. Thus, in patients at risk for gastrointestinal bleeding due to portal hypertension and a mild or moderate risk of recurrent thrombosis, the benefit-risk ratio of anticoagulation therapy is unclear.
The aim of this open randomised trial is to assess the efficacy of Xarelto 15mg/day, a new oral factor Xa inhibitor, in the recurrence of thromboembolic event and the risk of major bleeding compared to an untreated group in patients with chronic portal vein thrombosis without high risk thrombophilia.
The hypothesis of the trial is that treatment with Xarelto® would reduce the risk of recurrence of acute deep vein thrombosis (DVT) regardless location, with limited increase in the risk of hemorrhage in patients with chronic portal thrombosis and no high-risk factors for thrombosis recurrence
This is a national, multicentric, interventional study. 17 french centers already agreed to participate.
296 patients will be included on a 3 years period with 2 to 4 years treatment period. All data will be collected after informed consent will be obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Chronic Portal Vein Thrombosis
Keywords
thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xarelto
Arm Type
Experimental
Arm Description
15mg/day oral administration during 2 to 4 years (based on the recruitment date).
Arm Title
untreated
Arm Type
No Intervention
Arm Description
the patient won't receive any treatment during his study participation.
Intervention Type
Drug
Intervention Name(s)
Xarelto
Other Intervention Name(s)
Rivaroxaban
Intervention Description
15mg/day oral administration during 2 to 4 years (based on the recruitment date).
Primary Outcome Measure Information:
Title
Incidence of thromboembolic event in any territory ( splanchnic or extra splanchnic, lower limbs, cerebral veinous thrombosis, pulmonary embolism) or death
Description
In patients with chronic portal vein thrombosis without high risk thrombophilia, to assess the efficacy of Xarelto in the recurrence of thromboembolic event compared to absence of treatment.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Efficacy of xarelto
Description
Assess the efficacy regarding:
- Incidence of Pulmonary embolism, Deep vein thrombosis, Major bleedings and Portal hypertension bleeding, new non bleeding complication of portal hypertension, minor bleeding,
Time Frame
2 years
Title
Safety of xarelto
Description
Assess the safety regarding:
Toxicity of Xarelto, especially hepatic.
Gastrointestinal clinically relevant non major bleedings related to portal hypertension
Other gastrointestinal clinically relevant non major bleedings
Other adverse events
Survival (12months, 24 months and at the end of the follow up).
Time Frame
2 years
Title
Number of hospitalization during follow up.
Time Frame
2 years
Title
Evaluation of clotting activator marker with and without Xarelto.
Time Frame
2 years
Title
Duration of hospitalization during follow up.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients aged 18 to 90 years old
Patients either with :
Portal cavernoma radiologically confirmed, treated or not by anticoagulant
previous history of acute portal thrombosis for more than 6 months confirmed by angio-TDM or angio-MRI, repermeabilized or not
prophylaxis of gastro-intestinal bleeding due to portal hypertension, as recommended for cirrhosis patients. Upper gastro-intestinal endoscopy for less than 12 months
clinical examination
for women of childbearing age, contraception, either mecanichal or intra-uterin device, or oral progestative alone. No oral oestroprogestative contraception is allowed.
written informed consent
covered by a social security scheme or French "CMU"
Exclusion Criteria:
At least one High risk factors of thrombosis recurrence after review by the committee composed of an hepatologist and an hematologist specialist of hemostasis
Cirrhosis clinically or histologically confirmed or Budd-Chiari syndrome
Any disease leading to significant coagulopathy and clinically significant bleeding risk (platelets <50 000, or PT <30% without VKA, or Factor V <30% or Fibrinogen <0,8).
Personal or familial (1rst degree) history of spontanaeous deep vein thrombosis requiring anticoagulant treatment
pregnant or breast-feeding women
History of mesenteric veinous ischemia leading to intestinal resection
patient infected by HIV and treated by anti-protease
Formal indication to anticoagulant treatment for any reason
No possible follow-up
severe renal injury (creatinin clearance <30 ml/min)
Patients receiving a systemic treatment by azoled antifongic agent (such as ketoconazole, itraconazole, voriconazole or posaconazole), or a protease inhibitor. These are strong CYP3A4 and P-gp inhibitors.
Patients receiving a systemic treatment by rifampicyn or any other strong CYP3A4 inducting/stimulator (phenytoïne, carbamazepine, phenobarbital or millepertuis/Hypericum perforatum)
Hypersensitvity to rivaroxaban or excipients
active bleeding, or any condition at risk for significant major bleeding
Any other concomitant anticoagulant treatment, such as non-fractionnaed heparin, low-molecular weight heparin (enoxaparin, dalteparine, etc…), heparin derivatives (fondaparinux, etc), oral anticoagulant (warfarine, dabigatran etexilate, apixaban, etc) except in case of switch to Xarelto® or, in case of non-fractionnaed heparin administered to maintain central veinous or arterial catheterism permeability
Concomitant treatment by clopidogrel / Plavix® for acute coronary syndrome
hepatic transplantation
Intra-hepatic shunt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie Dr Plessier
Organizational Affiliation
Hôpital Beaujon - APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.
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