drugset / Trial / NCT01095185

Efficacy of Statin Association With Standard Treatment in Prevention of Recurrent Hemorrhage in Patient With Cirrhosis and Variceal Bleeding

NCT01095185

Phase 3 Completed 150 enrolled Juan A. Arnaiz
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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).

Timeline

Start
2010-11
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Simvastatin Small molecule 40 mg