Multicenter prospective randomized trial of the effect of rivaroxaban on survival and development of complications of portal hypertension in patients with cirrhosis - CIRROXABA

INSTITUTO DE INVESTIGACIONES BIOMEDICAS AUGUST PI I SUNYER (IDIBAPS)0 sites160 target enrollmentJuly 10, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: iver cirrhosis
Sponsor: INSTITUTO DE INVESTIGACIONES BIOMEDICAS AUGUST PI I SUNYER (IDIBAPS)
Enrollment: 160
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

July 10, 2015

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

INSTITUTO DE INVESTIGACIONES BIOMEDICAS AUGUST PI I SUNYER (IDIBAPS)

•a. Aged between 18 and 75 years of both sexes.
•b. Clinical and / or laboratory criteria, ultrasound and / or liver biopsy compatible with the diagnosis of viral cirrhosis (If HBV: HBV\-DNA must be negative; if HCV: SVR 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); NASH and cryptogenic.
•c. Presence of clinically significant portal hypertension (CSPHT) defined by clinical criteria (presence of esophageal varices or ascites), elastography (liver Fibroscan® ? 21 kPa) or hemodynamic (HVPG ? 10 mmHg)
•d. Mild to moderate hepatic impairment defined by Child\-Pugh of 7\-10 points.
•e. Written informed consent to participate in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 160
•F.1\.3 Elderly (\>\=65 years) yes

•a. Any previous or current thrombosis in splenoportal axis (must be ruled out by US\-Doppler earlier than one month after randomization; if doubts: AngioCT or AngioMRI if required).
•b. Background of hepatic encephalopathy grade II or higher
•c. Ascites that required prior practice of paracentesis in the last year
•d. Indication for use of anticoagulant and / or antiplatelet therapy for any reason.
•e. Hypersensitivity to the active ingredient or to excipients
•f. Active bleeding, clinically significant, or risk of major bleeding.
•g. Pregnancy and lactation.
•h. HCC or malignant neoplasia at the time of inclusion.
•i. Any comorbidity involving a therapeutic limitation and/or a life expectancy \<12 months.
•j. Existence of risk bleeding esophageal varices or prior variceal bleeding. They may not be included untill full treatment (stable beta blockers dosage or eradication trough varices ligation).