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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
15mg/day oral administration during 2 to 4 years (based on the recruitment date).
Hôpital Beaujon
Clichy, France
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.
Time frame: 2 years
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,
Time frame: 2 years
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).
Time frame: 2 years
Number of hospitalization during follow up.
Time frame: 2 years
Evaluation of clotting activator marker with and without Xarelto.
Time frame: 2 years
Duration of hospitalization during follow up.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.