Funding: VA Office of Research and Development
Investigators: Kaplan, DE; Taddei, TH
The SACRED Study is a prospective phase 3, double-blind, randomized, placebo-controlled, multi-center study. The study is being conducted at 10 VA centers across the country.
The primary objective is to test the effectiveness of simvastatin in reducing the incidence of hepatic decompensation, hepatocellular carcinoma, or all cause mortality in patients with cirrhosis at high risk. Secondary objectives include looking to explore the interaction of SLCO1B1 and KIF6 polymorphism on safety and clinical efficiency of statin therapy in patients with compensated cirrhosis, and to assess the impact of statin exposure on health related quality of life.
SARCRED expects to enroll 500 VA participants over 4 years at the following 10 VA sites: VA Connecticut Healthcare System, Corporal Michael J. Crescenz, San Francisco VA Medical Center, Hunter Holmes McGuire VA Medical Center, VA New York Harbor Health System, Boston VA Healthcare System, James J. Peters VA Medical Center, VA Puget Sound Health Care System, and Robley Rex VA Medical Center.
The Clinical Research Collaboration Unit (CRCU) functions in support of the research network to assure collaboration across sites, along with standardization and uniformity of procedures, to yield high-quality data.
The SACRED Study is registered on Clinical Trials.gov - Registration number: NCT03654053