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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Juan A. Arnaiz
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• Patients between 18 and 80 years old.

• Clinical criteria and/or analytical, ultrasound and/or liver biopsy consistent with the diagnosis of liver cirrhosis.

• Hematemesis or melenas within 7 days prior to study inclusion.

• Variceal bleeding. Endoscopic diagnosis:

• Active variceal bleeding.

• Clot or platelet cluster or,

• Esophageal varices associated to red blood in esophagogastric lumen in the absence of other sources of bleeding.

• Patients with standard treatment for prevention of recurrence of variceal bleeding (EVL+B Blockers,Propanolol).

• Women of childbearing age should have a urine pregnancy test negative for 7 days before commencement of treatment and postmenopausal women must have amenorrhea for at least 12 months to be considered not fertile. Potential childbearing women and men must commit to use adequate contraception prior to joining the study and during it.

• Written informed consent to participate in the study.

Exclusion Criteria:

• Pregnancy or lactation

• Presence multiple hepatocellular carcinoma or only diameter> 5 cm.

• Renal failure ( Creatinine > 2 mg/dl)

• Advanced liver disfunction (Child Pugh > 13 points)

• Contraindication for statins.

• Patients HIV treated with antiretroviral therapy.

• Pre-treatment with portosystemic shunt ( surgical or percutaneous).

• Bleeding due to gastric varices.

• Patients with total portal vein thrombosis or portal cavernomatosis.

• Patients previously treated with endoscopic variceal ligation and B- Blockers (before index episode).

• Patients previously treated with statins ( one month before the study).