Preoperative Statin Use and Major Adverse Cardiovascular Events in Liver Transplant Recipients

NCT07089589 | Completed

• 1 other identifier: 2025-0645
• Study Type: observational
• Target: 6,898
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this multicenter observational study is to determine whether preoperative statin use reduces major adverse cardiovascular events or other complications after liver transplantation. The main question it aims to answer is: Does preoperative statin use reduce major adverse cardiovascular events or other complications after liver transplantation? The records of participants who already took statins before liver transplantation will be reviewed.

Conditions

Major Adverse Cardiovascular Events; Liver Transplantation

Keywords

statin; liver transplantation; major adverse cardiovascular events

Outcome Measures

Primary Outcomes (1)

• 30-day Major Adverse Cardiovascular Events

  The composite of cardiovascular death, heart failure, myocardial infarction, atrial fibrillation, ventricular arrhythmia, ischemic electrocardiogram changes (ST-segment depression or elevation) with chest tightness, pulmonary embolism, and stroke

  30 days after liver transplantation

Secondary Outcomes (5)

• Acute Kidney Injury

  Within 7 days after liver transplantation

• Early Allograft Dysfunction

  Within 7 days after liver transplantation

• Intensive Care Unit Length of Stay

  From the date of liver transplantation until intensive care unit discharge, up to 600 days

• Overall Mortality

  From the date of liver transplantation to Mar 22, 2026

• Overall Graft Failure

  From the date of liver transplantation to Mar 22, 2026

Study Arms (2)

Control group

Patients who did not receive preoperative statin therapy

Statin group

Patients who received preoperative statin therapy

Drug: Preoperative Statin Use

Interventions

Preoperative Statin Use DRUG

Administration of any statin medication prior to liver transplantation. Statin therapy was previously prescribed by the treating physician before the transplant procedure, not assigned by the study protocol.

Also known as: HMG-CoA Reductase Inhibitor

Statin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) who underwent liver transplantation at Asan Medical Center, Samsung Medical Center, and Inje University Haeundae Paik Hospital in Korea between January 2008 and January 2026.

You may qualify if:

• \- Adult patients aged ≥18 years who underwent liver transplantation

You may not qualify if:

• Patients who underwent liver re-transplantation
• Patients with preoperative acute-on-chronic liver failure (ACLF)
• Patients with preoperative fulminant hepatic failure

Sponsors & Collaborators

• Asan Medical Center: lead
• Samsung Medical Center: collaborator
• Inje University Haeundae Paik Hospital: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 28, 2025
• Study Start: January 2, 2008
• Primary Completion: January 25, 2026
• Study Completion: March 22, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)