Cirrhosis Clinical Trial
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
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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