Major Adverse Cardiovascular EventsNCT07089589
Preoperative Statin Use and Major Adverse Cardiovascular Events in Liver Transplant Recipients
An observational study of Major Adverse Cardiovascular Events and Liver Transplantation, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Adverse Cardiovascular Events, Liver Transplantation
- What is being tested?
- Preoperative Statin Use
- How many people
- 6,898 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2008to 22 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients aged ≥18 years who underwent liver transplantation
Who cannot join
- Patients who underwent liver re-transplantation
- Patients with preoperative acute-on-chronic liver failure (ACLF)
- Patients with preoperative fulminant hepatic failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Statin Use and Major Adverse Cardiovascular Events in Liver Transplant Recipients: A Multicenter Retrospective Cohort Study
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.
Read the detailed description
Cardiovascular complications have emerged as a leading cause of early postoperative death following liver transplantation (LT), accounting for over 40% of early deaths. As a result, preventing postoperative cardiac complications has become a critical concern in the management of LT recipients.
Statin therapy has been suggested to improve perioperative and long-term outcomes in various surgical populations, primarily through LDL cholesterol reduction as well as pleiotropic effects, such as enhanced endothelial function and anti-inflammatory actions. However, evidence specifically examining the impact of preoperative statin therapy on cardiovascular outcomes after LT remains limited, highlighting the need for further research in this population.
This study aimed to address the current knowledge gap by investigating the association between preoperative statin use and the incidence of major adverse cardiovascular events within 30 days after liver transplantation in liver transplant recipients. Secondary outcomes included overall mortality, graft failure, early allograft dysfunction, acute kidney injury, and length of stay in the intensive care unit.
- Being tested
- Preoperative Statin Use
- Keywords
- statin, liver transplantation, major adverse cardiovascular events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Statin UseDrug
Also called HMG-CoA Reductase Inhibitor
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients who did not receive preoperative statin therapy | |
| Statin group | Patients who received preoperative statin therapy Receives: Drug: Preoperative Statin Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days after liver transplantation
Secondary outcomes (5)
Acute Kidney Injury
Occurrence of acute kidney injury within 7 days post-transplantation, diagnosed according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Measured: Within 7 days after liver transplantation
Early Allograft Dysfunction
Defined as serum bilirubin >10 mg/dL or international normalized ratio (INR) >1.6 on postoperative day (POD) 7, or alanine/aspartate aminotransferases >2000 IU/L within 7 days after transplantation
Measured: Within 7 days after liver transplantation
Intensive Care Unit Length of Stay
Total duration (days) of intensive care unit stay after liver transplantation
Measured: From the date of liver transplantation until intensive care unit discharge, up to 600 days
Overall Mortality
Death from any cause after liver transplantation
Measured: From the date of liver transplantation to Mar 22, 2026
Overall Graft Failure
Recipient death or retransplantation for any cause
Measured: From the date of liver transplantation to Mar 22, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start2 Jan 2008
- Primary completion25 Jan 2026
- Study completion22 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Adverse Cardiovascular EventsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,898 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Inje University Haeundae Paik Hospital
- Responsible party
- Principal investigator, Jun-Gol Song, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089589
- Sponsor's protocol ID
- 2025-0645
- Status last verified
- Apr 2026
- First submitted
- 18 Jul 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Statin Use and Major Adverse Cardiovascular Events in Liver Transplant Recipients: A Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07089589
- Acronym / sponsor ID
- 2025-0645
- Keywords
- statin, liver transplantation, major adverse cardiovascular events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,898 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Inje University Haeundae Paik Hospital
- Study start
- 2 Jan 2008 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 22 Mar 2026 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular complications have emerged as a leading cause of early postoperative death following liver transplantation (LT), accounting for over 40% of early deaths. As a result, preventing postoperative cardiac complications has become a critical concern in the management of LT recipients.
Statin therapy has been suggested to improve perioperative and long-term outcomes in various surgical populations, primarily through LDL cholesterol reduction as well as pleiotropic effects, such as enhanced endothelial function and anti-inflammatory actions. However, evidence specifically examining the impact of preoperative statin therapy on cardiovascular outcomes after LT remains limited, highlighting the need for further research in this population.
This study aimed to address the current knowledge gap by investigating the association between preoperative statin use and the incidence of major adverse cardiovascular events within 30 days after liver transplantation in liver transplant recipients. Secondary outcomes included overall mortality, graft failure, early allograft dysfunction, acute kidney injury, and length of stay in the intensive care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Patients who did not receive preoperative statin therapy |
| Statin group | – | Drug: Preoperative Statin UsePatients who received preoperative statin therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients aged ≥18 years who underwent liver transplantation
Key exclusion criteria (3 listed)
- Patients who underwent liver re-transplantation
- Patients with preoperative acute-on-chronic liver failure (ACLF)
- Patients with preoperative fulminant hepatic failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Statin UseAlso: HMG-CoA Reductase InhibitorAdministration 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. | Drug | Statin group |
Primary outcome
30-day Major Adverse Cardiovascular Events
Time frame: 30 days after liver transplantation
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
5 secondary outcomes
Acute Kidney Injury
Time frame: Within 7 days after liver transplantation
Early Allograft Dysfunction
Time frame: Within 7 days after liver transplantation
Intensive Care Unit Length of Stay
Time frame: From the date of liver transplantation until intensive care unit discharge, up to 600 days
Overall Mortality
Time frame: From the date of liver transplantation to Mar 22, 2026
Overall Graft Failure
Time frame: From the date of liver transplantation to Mar 22, 2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Adverse Cardiovascular Events and Liver Transplantation, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day Major Adverse Cardiovascular Events (time frame: 30 days after liver transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.