Statins for Prevention of Disease Progression and Hospitalization in Liver Cirrhosis (NCT04072601) | Clinical Trial Compass
TerminatedPhase 4
Statins for Prevention of Disease Progression and Hospitalization in Liver Cirrhosis
Stopped: Study part one completed
Denmark78 participantsStarted 2019-11-08
Plain-language summary
In a randomized, doubleblind and placebo-controlled trial we assess both clinical and cellular effects of atorvastatin in patients with liver cirrhosis.
162 participants will be allocated to atorvastatin 10-20 mg or placebo for 18 months. Clinical outcomes of survival, hospitalizations and safety will be evaluated. Also, the trial will investigate cellular functions in the liver by mass spectrometry proteomics, and single cell transcriptomics as well as exploring atorvastatin effects on different fenotypes by metagenomics.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients in the age of 18 to 80 years
* Patients with liver cirrhosis, diagnosed by liver biopsy or ultrasound or CT scan of the liver and clinical biochemistry compatible with cirrhosis within the past 3 months.
* In women, documented absence of pregnancy and unless in menopause commitment to use adequate contraception.
* Clinically significant portal hypertension with a hepatic venous pressure gradient measured by liver vein catheterization \>10 mmHg.
* Ability to read and understand project information in Danish and give written, informed consent.
Exclusion Criteria:
* People treated with statins within the last year.
* People with liver cirrhosis, with a clinically verified infection (standard biochemistry, culture) within the last four weeks.
* Pregnancy or lactation.
* Hepatocellular carcinoma
* HIV infection and treatment with protease inhibitors
* People in whom the clinician and investigators may have reason to doubt compliance to trial medication
* Clinical and biochemical signs of hepato-renal syndrome defined by current guidelines (EASL) within the last 14 days
* A MELD score above 23, or Child-Pugh score higher than 13.
* Hepatic encephalopathy grade 2 or higher
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite endpoint of numbers of death or liver transplantation
Timeframe: 1.5 years
2
Number of hospitalizations with liver related complications