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

• Status: Completed
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Rivaroxaban

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