Multicenter Prospective Randomized Trial of the Effect of Rivaroxaban on Survival and Development of Complications of Portal Hypertension in Patients With Cirrhosis

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the study will determine if patients with liver cirrhosis, anticoagulation free survival improves hypertension decompensation portal and / or transplantation without serious side effects. For it is conduct a double-blind multicenter clinical trial in which patients will be randomized to receive Rivaroxaban or placebo. It included 160 patients with liver cirrhosis and insufficiency mild to moderate hepatic. It will also analyze and develop secondary endpoint portal vein thrombosis. The confirmation of our hypothesis would lead to a radical change in treatment of patients with cirrhosis include treatment with Rivaroxaban in its drove.

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

Details

• Lead Sponsor: David Garcia Cinca
• Collaborator: IDIBAPS - Dr. Juan Carlos García Pagán
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• Aged between 18 and 75 years of both sexes.

• Clinical and / or laboratory criteria, ultrasound and / or liver biopsy compatible with the diagnosis of viral cirrhosis (If hepatitis B virus: hepatitis B virus-DNA must be negative; if hepatitis C virus: sustained virologic response should be at least for 6 months prior to enrollment); alcohol (in the last 6 months: in men less than 60 g daily intake in women less than 40 g); nonalcoholic steatohepatitis and cryptogenic.

• Presence of clinically significant portal hypertension defined by clinical criteria (presence of esophageal varices or ascites), elastography (liver Fibroscan® ? 21 kPa) or hemodynamic (Hepatic venous pressure gradient > 10 mmHg)

• Mild to moderate hepatic impairment defined by Child-Pugh of 7-10 points.

• Written informed consent to participate in the study

Exclusion Criteria:

• Any previous or current thrombosis in splenoportal axis (must be ruled out by US-Doppler earlier than one month after randomization; if doubts: computed tomography angiography or magnetic resonance angiography if required).

• Background of hepatic encephalopathy grade II or higher

• Ascites that required prior practice of paracentesis in the last year d. Indication for use of anticoagulant and / or antiplatelet therapy for any reason.

• Hypersensitivity to the active ingredient or to excipients

• Active bleeding, clinically significant, or risk of major bleeding.

• Pregnancy and lactation.

• Hepatocellular carcinoma or malignant neoplasia at the time of inclusion.

• Any comorbidity involving a therapeutic limitation and/or a life expectancy <12 months.

• Existence of risk bleeding esophageal varices or prior variceal bleeding. They may not be included until full treatment (stable beta blockers dosage or eradication trough varices ligation).

• Pregnancy or lactation.

• Severe thrombocytopenia <40,000 platelets / dl.

• Kidney failure (creatinine clearance <15ml / min).

• Transjugular intrahepatic portosystemic shunt or portosystemic shunt carrier.

• Child-Pugh score greater than 10.

• In hepatitis C virus liver cirrhosis patients: not carrying at least six months in sustained virologic response. In hepatitis B virus liver cirrhosis patients: hepatitis B virus DNA is not negative .

• Active alcoholism (60 g / day in men and 40 in women)

• Use of potent inhibitors of cytochrome cytochrome P450 3A4 (ketoconazole, protease inhibitor antiretroviral treatment in human immunodeficiency virus patients) or cytochrome inductors (rifampicin. Phenytoin ...).

• Participation in another clinical trial