Clinical trial · Interventional
Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Risk Compensated Cirrhosis
Effect of Simvastatin on Hepatic Decompensation and Death in Subjects With High-risk Compensated Cirrhosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
| Simvastatin 40mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Simvastatin
- description
- Simvastatin 40mg PO once at bedtime for up to 24 months. Note: all enrolled subjects will trial 20mg once at bedtime for two weeks as lead-in to determine tolerability prior to randomization.
- interventionNames
- Drug: Simvastatin 40mg
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo 40mg PO once at bedtime for up to 24 months. Note: all enrolled subjects will trial 20mg once at bedtime for two weeks as lead-in to determine tolerability prior to randomization.
- interventionNames
- Drug: Placebo Oral Tablet
Primary outcomes (1)
- measure
- Survival free from hepatic decompensation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 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
References
Publications (1)
- BACKGROUNDKaplan DE, Mehta R, Garcia-Tsao G, Albrecht J, Aytaman A, Baffy G, Bajaj J, Hernaez R, Hunt K, Ioannou G, Johnson K, Kanwal F, Lee TH, Monto A, Pandya P, Schaubel D, Taddei TH. SACRED: Effect of simvastatin on hepatic decompensation and death in subjects with high-risk compensated cirrhosis: Statins and Cirrhosis: Reducing Events of Decompensation. Contemp Clin Trials. 2021 May;104:106367. doi: 10.1016/j.cct.2021.106367. Epub 2021 Mar 24. PMID 33771685