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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01095185
Other study ID # BLEPS
Secondary ID 2009-016500-24
Status Completed
Phase Phase 3
First received March 29, 2010
Last updated March 18, 2015
Start date November 2010
Est. completion date September 2013

Study information

Verified date March 2015
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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).


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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).

Study Design

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


Intervention

Drug:
Simvastatin
Simvastatin 20 mg for 15 days, then 40 mg until the end of the study.
Placebo
Simvastatin placebo

Locations

Country Name City State
Spain Hospital Universitario de Alicante Alicante
Spain Hospital Clinic Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital de la Vall d'Hebron Barcelona
Spain Hospital German Trias i Pujol Barcelona
Spain Hospital Universitario del Mar Barcelona
Spain Hospital Universitari Bellvitge L´Hospitalet del LLobregat Barcelona
Spain Hospital Arnau de Vilanova LLeida Catalunya
Spain Hospital Gregorio Marañon Madrid
Spain Hospital Ramón y Cajal Madrid
Spain Hospital Puerta del Hierro Majadahonda Madrid
Spain Complejo Universitario Central de Asturias Oviedo Asturias
Spain Complejo Hospitalario Pontevedra Pontevedra Galicia
Spain Corporació Sanitària Parc Tauli Sabadell Barcelona
Spain Hospital Universitario de Canarias Tenerife

Sponsors (1)

Lead Sponsor Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence of variceal bleeding and patient survival 12 months No
Secondary Bleeding severity in both arms. 12 months No
Secondary Appearance or progression of Portal Hypertension complications 12 months No
Secondary Appearance or progression of Portal Vein Thrombosis 12 months No
Secondary Need for alternative treatments (transjugular intrahepatic portosystemic shunt [TIPS], surgery) 12 months No
Secondary Incidence of adverse events of statin treatment 12 months Yes
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