Efficacy of Statin Association With Standard Treatment in Prevention of Recurrent Hemorrhage in Patient With Cirrhosis and Variceal Bleeding
|ClinicalTrials.gov Identifier: NCT01095185|
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : March 19, 2015
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).
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis Hypertension, Portal Bleeding Esophageal Varices Portal Vein Thrombosis||Drug: Simvastatin Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
U.S. FDA Resources
Experimental: Standard therapy + Simvastatin
Simvastatin 20 mg for 15 days, then 40 mg until the end of the study.
Placebo Comparator: Standard therapy + placebo
- Recurrence of variceal bleeding and patient survival [ Time Frame: 12 months ]
- Bleeding severity in both arms. [ Time Frame: 12 months ]
- Appearance or progression of Portal Hypertension complications [ Time Frame: 12 months ]
- Appearance or progression of Portal Vein Thrombosis [ Time Frame: 12 months ]
- Need for alternative treatments (transjugular intrahepatic portosystemic shunt [TIPS], surgery) [ Time Frame: 12 months ]
- Incidence of adverse events of statin treatment [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095185
|Complejo Universitario Central de Asturias|
|Oviedo, Asturias, Spain|
|Hospital Universitari Bellvitge|
|L´Hospitalet del LLobregat, Barcelona, Spain|
|Corporació Sanitària Parc Tauli|
|Sabadell, Barcelona, Spain|
|Hospital Arnau de Vilanova|
|LLeida, Catalunya, Spain|
|Complejo Hospitalario Pontevedra|
|Pontevedra, Galicia, Spain|
|Hospital Puerta del Hierro|
|Majadahonda, Madrid, Spain|
|Hospital Universitario de Alicante|
|Barcelona, Spain, 08005|
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08041|
|Hospital German Trias i Pujol|
|Barcelona, Spain, 089016|
|Hospital de la Vall d'Hebron|
|Hospital Universitario del Mar|
|Hospital Gregorio Marañon|
|Hospital Ramón y Cajal|
|Hospital Universitario de Canarias|
|Principal Investigator:||Jaume Bosch, MD||Hospital Clínic|