Multicenter Prospective Randomized Trial of the Effect of Rivaroxaban on Survival and Development of Complications of Portal Hypertension in Patients With Cirrhosis (CIRROXABAN)
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|ClinicalTrials.gov Identifier: NCT02643212|
Recruitment Status : Unknown
Verified April 2018 by David Garcia Cinca, Hospital Clinic of Barcelona.
Recruitment status was: Recruiting
First Posted : December 31, 2015
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis||Drug: Rivaroxaban Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
|Placebo Comparator: Placebo||
Rivaroxaban 10mg, 1 once a day
- Survival free of transplant and decompensation / complications of portal hypertension. [ Time Frame: At month 24 ]
Is defined as decompensation / complications of portal hypertension:
- significant bleeding episode (defined as Baveno V) by portal hypertension (esophageal varices, gastric varices; gastropathy Portal Hypertension)
- Hepatic encephalopathy grade II or higher.
- decompensation of ascites: In patients without ascites decompensation be considered the onset of clinically detectable ascites and confirmed by utrasounds de novo; whereas in those with previous ascites will be considered end-point for worsening ascites if required: a) perform two or more paracentesis evacuator in the next 6 months, or b) the completion of a Transjugular intrahepatic portosystemic shunt.
- Cirrhosis progression disease (bleeding episode, encephalopathy, ascitis) [ Time Frame: At month 24 ]
- Bleeding episode due to portal hypertension.
- Hepatic encephalopathy grade II or higher.
- Ascitic decompensation: In patients without ascites, decompensation defined as "de novo" clinically detectable ascites; whereas in those with previous ascites is considered end-point for worsening ascites if required: a) perform two or more evacuative paracentesis in the following six months, or b) the completion of a TIPS
- Development of portal vein thrombosis detected by ultrasound and confirmed by CT angiography or MRI angiography [ Time Frame: At month 24 ]
- To evaluate the efficacy in preventing complications of portal hypertension [ Time Frame: At month 24 ]Development of complications of portal hypertension (anamnesis, physical examination, ultrasound and fibrogastroscopy)
- Security of rivaroxaban in patients with liver cirrhosis, number of adverse events and adverse reactions in each arm of study. History and clinical evaluation of bleeding and monitoring of hematocrit. Evaluation of liver function [ Time Frame: At month 24 ]Evaluate number of bleeding episodes, hematocrit values and number of adverse events and reactions.
- To evaluate the incidence of hepatocellular carcinoma [ Time Frame: At month 24 ]Incidence of hepatocellular carcinoma by semiannual ultrasound.
- Effect on splenic and liver elasticity measured by fibroscan and / or acoustic radiation force impulse. [ Time Frame: At month 24 ]Effect of rivaroxaban on liver fibrosis assessed by liver elastography measured by fibroscan and / or acoustic radiation force impulse at baseline and every six months conditions.
- Effect of Rivaroxaban on hepatocellular function estimated by the Child-Pugh and the model for end-stage liver disease scores. [ Time Frame: At month 24 ]
- To correlate levels of anti-factor Xa and Rivaroxaban on survival free of transplant, cirrhosis progression disease (bleeding episode, encephalopathy, ascitis) and number of adverse events and reactions. [ Time Frame: At month 24 ]To correlate levels of Rivaroxaban and anti-factor Xa to the efficacy and safety of the drug. Rivaroxaban
- To evaluate the effect of Rivaroxaban on hepatic venous pressure gradient [ Time Frame: At month 24 ]Effect on hepatic venous pressure gradient. Determination of hepatic venous pressure gradient at baseline and 12 months rivaroxaban or placebo
- To assess if Rivaroxaban reduces concentration of intestinal fatty acid binding protein, 16S ribosomal DNA, CD14, interleukin 6, lipopolysaccharide binding protein and lipopolysaccharide [ Time Frame: At month 24 ]Assess Rivaroxaban reduces bacterial translocation and proinflammatory cytokines. Correlation with clinical events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643212
|Contact: Juan Carlos García Pagan, MD||+34 93 227 54 00|
|Contact: David Garcia Cinca||+34 93 227 54 email@example.com|
|Hospital Universitario Central de Asturias||Recruiting|
|Oviedo, Asturias, Spain, 33011|
|Principal Investigator: Carmen Alvarez-Navascués|
|Hospital German Trias i Pujol||Not yet recruiting|
|Badalona, Barcelona, Spain, 08916|
|Principal Investigator: Betty Paola Morales|
|Hospital Universitari de Bellvitge||Recruiting|
|Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Principal Investigator: José Castellote|
|Hospital Universitario Marqués de Valdecilla||Recruiting|
|Santander, Cantabria, Spain, 39008|
|Principal Investigator: Angela Puente|
|Hospital Universitario Puerta de Hierro de Majadahonda||Not yet recruiting|
|Majadahonda, Madrid, Spain, 28222|
|Principal Investigator: José Luis Calleja|
|Hospital de la Santa Creu i Sant Pau.||Not yet recruiting|
|Barcelona, Spain, 08025|
|Principal Investigator: Càndid Villanueva|
|Hospital Vall d´Hebron||Not yet recruiting|
|Barcelona, Spain, 08035|
|Principal Investigator: Joan Genescà|
|Hospital Clínic i Provincial de Barcelona||Recruiting|
|Barcelona, Spain, 08036|
|Principal Investigator: Juan Carlos Garcia-Pagan, MD|
|Hospital Arnau de Vilanova||Recruiting|
|Lérida, Spain, 25198|
|Principal Investigator: Carles Aracil|
|Hospital Gregorio Marañón||Not yet recruiting|
|Madrid, Spain, 28007|
|Principal Investigator: Rafael Bañares|
|Hospital Ramón y Cajal||Recruiting|
|Madrid, Spain, 28034|
|Principal Investigator: Agustin Albillos|
|Complejo Hospitalario de Pontevedra_Hospital Montecelo||Recruiting|
|Pontevedra, Spain, 36471|
|Principal Investigator: Juan Turnes|
|Hospital Universitario Tenerife||Not yet recruiting|
|Tenerife, Spain, 38320|
|Principal Investigator: Manuel Hernández-Guerra de Aguilar|
|Hospital universitari i politècnic La Fe de Valencia||Not yet recruiting|
|Valencia, Spain, 46026|
|Principal Investigator: María Berenguer|