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| Name | Class |
|---|---|
| IDIBAPS - Dr. Juan Carlos García Pagán | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Rivaroxaban | Experimental | Rivaroxaban 10mg, 1 once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Survival free of transplant and decompensation / complications of portal hypertension. | Is defined as decompensation / complications of portal hypertension:
| At month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Cirrhosis progression disease (bleeding episode, encephalopathy, ascitis) |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Carlos García Pagan, MD | Contact | +34 93 227 54 00 | ||
| David Garcia Cinca | Contact | +34 93 227 54 00 | dgarcia@clinic.ub.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital German Trias i Pujol | Not yet recruiting | Badalona | Barcelona | 08916 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40691992 | Derived | 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. |
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|
| At month 24 |
| Development of portal vein thrombosis detected by ultrasound and confirmed by CT angiography or MRI angiography | At month 24 |
| To evaluate the efficacy in preventing complications of portal hypertension | Development of complications of portal hypertension (anamnesis, physical examination, ultrasound and fibrogastroscopy) | At month 24 |
| 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 | Evaluate number of bleeding episodes, hematocrit values and number of adverse events and reactions. | At month 24 |
| To evaluate the incidence of hepatocellular carcinoma | Incidence of hepatocellular carcinoma by semiannual ultrasound. | At month 24 |
| Effect on splenic and liver elasticity measured by fibroscan and / or acoustic radiation force impulse. | 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. | At month 24 |
| Effect of Rivaroxaban on hepatocellular function estimated by the Child-Pugh and the model for end-stage liver disease scores. | 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. | To correlate levels of Rivaroxaban and anti-factor Xa to the efficacy and safety of the drug. Rivaroxaban | At month 24 |
| To evaluate the effect of Rivaroxaban on hepatic venous pressure gradient | Effect on hepatic venous pressure gradient. Determination of hepatic venous pressure gradient at baseline and 12 months rivaroxaban or placebo | At month 24 |
| To assess if Rivaroxaban reduces concentration of intestinal fatty acid binding protein, 16S ribosomal DNA, CD14, interleukin 6, lipopolysaccharide binding protein and lipopolysaccharide | Assess Rivaroxaban reduces bacterial translocation and proinflammatory cytokines. Correlation with clinical events. | At month 24 |
| Hospital Universitari de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
|
| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | Cantabria | 39008 | Spain |
|
| Hospital Universitario Puerta de Hierro de Majadahonda | Not yet recruiting | Majadahonda | Madrid | 28222 | Spain |
|
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
|
| Hospital de la Santa Creu i Sant Pau. | Not yet recruiting | Barcelona | 08025 | Spain |
|
| Hospital Vall d´Hebron | Not yet recruiting | Barcelona | 08035 | Spain |
|
| Hospital Clínic i Provincial de Barcelona | Recruiting | Barcelona | 08036 | Spain |
|
| Hospital Arnau de Vilanova | Recruiting | Lleida | 25198 | Spain |
|
| Hospital Gregorio Marañón | Not yet recruiting | Madrid | 28007 | Spain |
|
| Hospital Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
|
| Complejo Hospitalario de Pontevedra_Hospital Montecelo | Recruiting | Pontevedra | 36471 | Spain |
|
| Hospital Universitario Tenerife | Not yet recruiting | Santa Cruz de Tenerife | 38320 | Spain |
|
| Hospital universitari i politècnic La Fe de Valencia | Not yet recruiting | Valencia | 46026 | Spain |
|
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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