PROSPECTIVE, RANDOMISED, MULTICENTER STUDY TO ASSESS THE EFFECT OF RIVAROXABAN ON THE RECANALISATION OF PORTAL VENOUS THROMBOSIS AND SURVIVAL IN PATIENTS WITH CIRRHOSIS AND PORTAL VENOUS THROMBOSIS (Q3143468): Difference between revisions
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(Created claim: summary (P836): There is currently no effective treatment to change the natural history of cirrhosis in its later stages. Porta vein thrombosis is a common phenomenon in patients with liver cirrhosis, especially in those with more advanced disease. The real impact of porta vein thrombosis on survival and risk of decompensation in patients with cirrhosis is little known and the evidence available to date indicates that the prognosis does not worsen. Despite this...) |
(Changed label, description and/or aliases in en: translated_label) |
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PROSPECTIVE, RANDOMISED, MULTICENTER STUDY TO ASSESS THE EFFECT OF RIVAROXABAN ON THE RECANALISATION OF PORTAL VENOUS THROMBOSIS AND SURVIVAL IN PATIENTS WITH CIRRHOSIS AND PORTAL VENOUS THROMBOSIS | |||
Revision as of 13:29, 12 October 2021
Project Q3143468 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | PROSPECTIVE, RANDOMISED, MULTICENTER STUDY TO ASSESS THE EFFECT OF RIVAROXABAN ON THE RECANALISATION OF PORTAL VENOUS THROMBOSIS AND SURVIVAL IN PATIENTS WITH CIRRHOSIS AND PORTAL VENOUS THROMBOSIS |
Project Q3143468 in Spain |
Statements
50,750.0 Euro
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101,500.0 Euro
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50.0 percent
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1 January 2017
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31 March 2020
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FUNDACION INVESTIGACION BIOMEDICA HOSPITAL RAMON Y CAJAL
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40°25'0.12"N, 3°42'12.89"W
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28079
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Actualmente se carece de tratamientos eficaces que modifiquen la historia natural de la cirrosis en sus fases más tardías. La trombosis de la vena porta es un fenómeno frecuente en los pacientes con cirrosis hepática, sobre todo en aquellos con enfermedad más avanzada. El impacto real de la trombosis de la vena porta sobre la supervivencia y riesgo de descompensación en los enfermos con cirrosis es poco conocido y la evidencia disponible hasta la fecha indica que no empeora el pronóstico. Pese a ello, actualmente existe una mayor tendencia a iniciar tratamiento anticoagulante cuando la trombosis es extensa o afecta a otros vasos esplácnicos. El beneficio de esta estrategia aún se encuentra por definir. Puesto que la cirrosis avanzada supone una situación procoagulante que a su vez se relaciona con una mayor progresión de la cirrosis, se ha propuesto que revertir dicho estado mediante terapia anticoagulante proporcionaría un beneficio en términos de supervivencia. Esta hipótesis ha sido corroborada en un estudio clínico que no incluía pacientes con trombosis portal. Actualmente se desconoce si la anticoagulación en pacientes con cirrosis y trombosis portal modifica la historia natural de la cirrosis y si dicha modificación es independiente del efecto de la misma sobre la recanalización de la trombosis. Proponemos un estudio en el que el objetivo principal es demostrar que la anticoagulación con rivaroxaban mejora la supervivencia libre de trasplante y de descompensaciones, sin desarrollar hemorragia u otras complicaciones, sin progresión de la trombosis. Para ello se realizará un ensayo clínico multicéntrico doble ciego en el que los pacientes con cirrosis y trombosis portal se aleatorizarán a recibir rivaroxaban o placebo. (Spanish)
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There is currently no effective treatment to change the natural history of cirrhosis in its later stages. Porta vein thrombosis is a common phenomenon in patients with liver cirrhosis, especially in those with more advanced disease. The real impact of porta vein thrombosis on survival and risk of decompensation in patients with cirrhosis is little known and the evidence available to date indicates that the prognosis does not worsen. Despite this, there is currently a greater tendency to initiate anticoagulant treatment when thrombosis is extensive or affects other splastic vessels. The benefit of this strategy is still to be defined. Since advanced cirrhosis is a procoagulant situation that in turn is related to a greater progression of cirrhosis, it has been proposed that reversing this state through anticoagulant therapy would provide a benefit in terms of survival. This hypothesis has been corroborated in a clinical study that did not include patients with portal thrombosis. It is currently unknown whether anticoagulation in patients with cirrhosis and portal thrombosis modifies the natural history of cirrhosis and whether this modification is independent of the effect of cirrhosis on the recanalisation of thrombosis. We propose a study in which the main objective is to demonstrate that rivaroxaban anticoagulation improves transplant-free survival and decompensation, without developing bleeding or other complications, without progression of thrombosis. This will be done in a double-blind, multicenter clinical trial in which patients with cirrhosis and portal thrombosis will be randomised to receive rivaroxaban or placebo. (English)
12 October 2021
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Madrid
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Identifiers
PI16_01835
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