Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Risk Compensated Cirrhosis
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Cirrhosis
In brief
This phase III, randomized, double-blind, placebo-controlled, multi-center study seeks to test whether simvastatin, a statin usually used to lower cholesterol to prevent heart problems and strokes, can lower the risk of hepatic decompensation (developing symptoms of cirrhosis) in U.S. Veterans who have compensated cirrhosis (the liver is scarred and damaged but there are no symptoms). The study will also explore how changes or differences in genes effect the safety and effectiveness of using statins and how the use of statins affects quality of life.
Key facts
- Study ID
- NCT03654053
- Run by
- VA Office of Research and Development
- People needed
- 142
- Starts
- 2020-10-02
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-01-07
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- U.S. Veteran
- Cirrhosis due to chronic viral hepatitis, or alcohol or non-alcoholic fatty liver
- Compensated cirrhosis (history of endoscopically-confirmed variceal hemorrhage, absence of overt ascites, history of overt non-precipitated encephalopathy)
- Age > 18 and <= 80
- High risk of cirrhosis decompensation as defined by any of the following:
- Presence of esophageal varices on endoscopy
- Presence of portosystemic collaterals on imaging as determined by a body radiologist
- Fibroscan VCTE >= 20kPa
- Platelet count <= 125 K/mm
- 44 total points (\~50% of clinically significant portal hypertension using the ANTICIPATE Nomogram)
- Competent to provide informed consent
You may not qualify if…
- Prior exposure to any statin within 6 months
- Prior allergy or sensitivity to simvastatin
- History of variceal hemorrhage confirmed endoscopically within the previous 3 years
- Presence of overt ascites or treatment with diuretics for ascites with 6 months
- History of chronic, recurrent or episodic overt hepatic encephalopathy with asterixis within 6 months
- History of hepatocellular carcinoma
- Child-Turcotte-Pugh C Stage (CTP Score > 9)
- Prior receipt of organ transplant
- Participation in another pharmacological clinical trial within 3 months of the current study
- Pregnancy or anticipated pregnancy within 2 years
- Breast Feeding
- Patients with life expectancy < 3 years due to comorbid conditions
- Independent indication for initiation of statin therapy
- Patients with any form of clinical atherosclerotic cardiovascular disease (ASCVD)
- Patients with primary LDL-C < 190 mg/dl
- Patients with diabetes mellitus, age 40-75 years, with LDL-C levels >=130 mg/dl
- Need for concomitant administration of potent inhibitors of CYP34A4 enzymes (medications or other supplements that should not be taken with simvastatin, including cyclosporine, danazol, gemfibrozil, fenofibrate, extended release niacin, itraconazole, ketoconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, macrolide antibiotics - erythromycin, clarithromycin, telithromycin, nefazadone, amlodipine, verapamil, diltiazem, dronedarone, amiodarone, renolazine, lomitapide, and cobicistat)
- Prior TIPSS shunt
- Hemodialysis
Where it is running
- San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States
- Robley Rex VA Medical Center, Louisville, KY — Louisville, Kentucky, United States
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States
- Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY — Brooklyn, New York, United States
- James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States
- Philadelphia MultiService Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
- Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond, Virginia, United States
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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