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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 17, 2015

Keywords

ClinConnect Summary

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.

Ga...

Gender

ALL

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