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

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.

Timeline

Start

2016-05

Primary completion

2019-12

Completion

2019-12

Outcome

Missed primary endpoint

paper Although the reduction in the primary endpoint did not reach statistical significance in the overall cohort PMID 40691992 ↗

paper 54.4% and 43.0% in the placebo group, compared to 78.7% and 67.1% in the rivaroxaban group (log-rank p = 0.058). PMID 40691992 ↗

Publications

• Puente A, Turon F, Martinez J, Fortea JI, Guerra MH, Alvarado E, Pons M, Magaz M, Llop E, Alvarez-Navascues C, Navarrete AA, Berenguer M, Masnou H, Banares R, Casado M, Ampuero J, Rios J, Saavedra C, Blasi A, Lisman T, Figuero CR, Huelin P, Tellez L, Arraez DM, Rodriguez M, Aguilera V, Arias Loste MT, Baiges A, Hernandez-Gea V, Perello C, Calleja JL, Genesca J, Villanueva C, Gonzalez-Alayon C, Albillos A, Crespo J, Garcia-Pagan JC. Rivaroxaban to prevent complications of portal hypertension in cirrhosis: The CIRROXABAN study. J Hepatol. 2025 Nov;83(5):1069-1076. doi: 10.1016/j.jhep.2025.06.035. Epub 2025 Jul 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rivaroxaban	Other / unclassified	10 mg	Oral

Indications