MedTrace Logo

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

NCT01095185 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-03-19

No results posted yet for this study

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).

Conditions

  • Cirrhosis
  • Hypertension, Portal
  • Bleeding Esophageal Varices
  • Portal Vein Thrombosis

Interventions

DRUG

Simvastatin

Simvastatin 20 mg for 15 days, then 40 mg until the end of the study.

DRUG

Placebo

Simvastatin placebo

Sponsors & Collaborators

  • Juan A. Arnaiz

    lead OTHER

Principal Investigators

  • Jaume Bosch, MD · Hospital Clínic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01095185 on ClinicalTrials.gov