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Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis. (RIPORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02555111
Recruitment Status : Completed
First Posted : September 21, 2015
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Chronic Portal Vein Thrombosis Drug: Xarelto Phase 3

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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentric Randomized Study of Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.
Actual Study Start Date : September 2015
Actual Primary Completion Date : February 2020
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: Xarelto
15mg/day oral administration during 2 to 4 years (based on the recruitment date).
Drug: Xarelto
15mg/day oral administration during 2 to 4 years (based on the recruitment date).
Other Name: Rivaroxaban

No Intervention: untreated
the patient won't receive any treatment during his study participation.



Primary Outcome Measures :
  1. Incidence of thromboembolic event in any territory (arterial or venous, splanchnic or extra splanchnic) or death [ Time Frame: 2 years ]
    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 :
  1. Efficacy of xarelto [ Time Frame: 2 years ]

    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,


  2. Safety of xarelto [ Time Frame: 2 years ]

    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).

  3. Number of hospitalization during follow up. [ Time Frame: 2 years ]
  4. Evaluation of clotting activator marker with and without Xarelto. [ Time Frame: 2 years ]
  5. Duration of hospitalization during follow up. [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 90 years old >Adults > 18 years old
  • Patients Either affected by cavernous portal, with a constituted diagnostic on radiological criteria, treated or not with anticoagulant Or acute portal thrombosis history dating back more than 6 months, documented by angiography or angio-MRI ; followed or not by a repermeabilize.
  • Patient who was used prophylaxis for gastrointestinal bleeding in portal hypertension, according to current consensus recommendations for patients with cirrhosis
  • Barrier contraception or intrauterine device (with or without progestin), for women of childbearing age, or progestin alone. Do not use combined hormonal contraception.

Exclusion Criteria:

  • Presence of a high risk factor of recurrence of thrombosis veinous after review of the medical file by a validation committee composed of an hepatologist and a hematologist physician hemostasis specialist.
  • Disease with relevant coagulopathy and bleeding risk clinically relevant (platelet < 50 000, or TP <30 % without AVK or Factor V < 30% ou fibrinogen < 0.8)
  • Cirrhosis clinically relevant or with histological test or Budd Chiari syndrome.
  • Personnel or first degree familial past history of spontaneous (unprovoked) deep vein thrombosis require an anticoagulant treatment
  • Pregnancy and breast feeding women
  • Past history of mesenteric infarction
  • Absolute necessity of anticoagulation whatever the cause
  • Galactose intolerance, Lapp lactase deficiency, malabsorption of glucose and galactose
  • HIV positive and treated by antiprotease
  • Patient with impossible follow up
  • Severe renal failure (creatinin clearance < 30 ml/min)
  • Concomitant treatment with ketoconazole, l'itraconazole, le voriconazole or posaconazole, or HIV protease inhibitor, potent CYP3A4 and P-gp inhibitors
  • Simultaneous treatment with rifampicin or other CYP3A4 inductor
  • Hypersensitivity to Xarelto or one of the excipients
  • Progressive bleeding, clinically relevant including lesion or disease with significant risk of major bleeding.
  • Concomitant treatment with other anticoagulant (unfractionated heparin (UFH), low molecular weight heparin (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban, etc.), unless relay with Xarelto® or "vice-versa", or when administered at doses f UFH necessary to maintain the permeability of a central venous or arterial catheter.
  • Concomitant treatment of acute coronary syndrome clopidogrel / Plavix®
  • Liver transplantation
  • Transjugular intrahepatic portosystemic shunt

Information from the National Library of Medicine

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): NCT02555111


Locations
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France
Hôpital Beaujon
Clichy, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Aurélie Dr Plessier Hôpital Beaujon - APHP
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02555111    
Other Study ID Numbers: AOM 11077 - P 110150
2015-001190-40 ( EudraCT Number )
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
thrombosis
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants