Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects … (NCT03654053) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Risk Compensated Cirrhosis
United States142 participantsStarted 2020-10-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 initiatio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.