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ACTIVE NOT RECRUITING
NCT03654053
PHASE3

Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Risk Compensated Cirrhosis

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Official title: Effect of Simvastatin on Hepatic Decompensation and Death in Subjects With High-risk Compensated Cirrhosis

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2020-10-02

Completion Date

2026-12-31

Last Updated

2026-01-07

Healthy Volunteers

No

Conditions

Interventions

DRUG

Placebo Oral Tablet

Placebo taken once nightly at bed time.

DRUG

Simvastatin 40mg

Simvastatin 40mg taken once nightly at bed time.

Locations (11)

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