๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-01-06

Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Risk Compensated Cirrhosis (NCT03654053)

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

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: VA Office of Research and Development

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 join: Review the eligibility criteria below.

Location: San Francisco VA Medical Center, San Francisco, CA โ€” San Francisco, California

Age range: 18 Years to 80 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (11 Sites)

  • San Francisco VA Medical Center, San Francisco, CA โ€” San Francisco, California
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT โ€” West Haven, Connecticut
  • Robley Rex VA Medical Center, Louisville, KY โ€” Louisville, Kentucky
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA โ€” Boston, Massachusetts
  • Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY โ€” Brooklyn, New York
  • James J. Peters VA Medical Center, Bronx, NY โ€” The Bronx, New York
  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA โ€” Philadelphia, Pennsylvania
  • Philadelphia MultiService Center, Philadelphia, PA โ€” Philadelphia, Pennsylvania
  • Michael E. DeBakey VA Medical Center, Houston, TX โ€” Houston, Texas
  • Hunter Holmes McGuire VA Medical Center, Richmond, VA โ€” Richmond, Virginia
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA โ€” Seattle, Washington

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Cirrhosis clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—