Efficacy of Statin Association With Standard Treatment in Prevention of Recurrent Hemorrhage in Patient With Cirrhosis and Variceal Bleeding
This is a prospective, double blind controlled trial in which patients with esophagic variceal bleeding treated with standard therapy (endoscopic variceal ligation(EVL) + B-blockers), will be randomized to receive statins or placebo. They will be followed up during 12 months to determinate whether statins are effective in prevention of variceal bleeding recurrence and evaluate patient survival.
Randomization will be stratified according to the degree of hepatic insufficiency, assessed by the Child-Pugh classifications (A,B or C).
|Cirrhosis Hypertension, Portal Bleeding Esophageal Varices Portal Vein Thrombosis||Drug: Simvastatin Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Multicenter,Double Blind,Controlled With Placebo Trial About Efficacy of Statin Association With Standard Treatment in Prevention of Recurrent Hemorrhage in Patient With Liver Cirrhosis and Variceal Bleeding|
- Recurrence of variceal bleeding and patient survival [ Time Frame: 12 months ]
- Bleeding severity in both arms. [ Time Frame: 12 months ]
- Appearance or progression of Portal Hypertension complications [ Time Frame: 12 months ]
- Appearance or progression of Portal Vein Thrombosis [ Time Frame: 12 months ]
- Need for alternative treatments (transjugular intrahepatic portosystemic shunt [TIPS], surgery) [ Time Frame: 12 months ]
- Incidence of adverse events of statin treatment [ Time Frame: 12 months ]
|Study Start Date:||November 2010|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Standard therapy + Simvastatin
Simvastatin 20 mg for 15 days, then 40 mg until the end of the study.
Placebo Comparator: Standard therapy + placebo
A mayor cause of cirrhosis-related morbility and mortality is the development of variceal hemorrhage, a direct consequence of portal hypertension. In addition, survivors of an episode of active bleeding have a 70 % risk of recurrent hemorrhage within two years of the bleeding episode and the highest risk it is situated in the first six weeks after the hemorrhage episode.
The recommended treatment in AASLD guidelines is the combination of non selective Betablockers with endoscopic treatment with EVL, with high recurrence (30% in 2 years).
The hypothesis of this study is that statins are candidates for improving portal hypertension treatment in patients with cirrhosis, improving vascular function as well as preventing venous thrombotic events.
Patients with liver cirrhosis and variceal bleeding with standard treatment will be stratified and after randomized to undergo either statins (20 mg for 15 days, and after 40 mg/day) or placebo. They will be followed up for 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095185
|Complejo Universitario Central de Asturias|
|Oviedo, Asturias, Spain|
|Hospital Universitari Bellvitge|
|L´Hospitalet del LLobregat, Barcelona, Spain|
|Corporació Sanitària Parc Tauli|
|Sabadell, Barcelona, Spain|
|Hospital Arnau de Vilanova|
|LLeida, Catalunya, Spain|
|Complejo Hospitalario Pontevedra|
|Pontevedra, Galicia, Spain|
|Hospital Puerta del Hierro|
|Majadahonda, Madrid, Spain|
|Hospital Universitario de Alicante|
|Barcelona, Spain, 08005|
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08041|
|Hospital German Trias i Pujol|
|Barcelona, Spain, 089016|
|Hospital de la Vall d'Hebron|
|Hospital Universitario del Mar|
|Hospital Gregorio Marañon|
|Hospital Ramón y Cajal|
|Hospital Universitario de Canarias|
|Principal Investigator:||Jaume Bosch, MD||Hospital Clínic|