Simvastatin in the Prevention of Recurrent Pancreatitis (NCT04021498) | Clinical Trial Compass
TerminatedPhase 3
Simvastatin in the Prevention of Recurrent Pancreatitis
Stopped: Slow recruitment
Spain83 participantsStarted 2017-09-29
Plain-language summary
Recurrent acute pancreatitis and recurrent relapses of inflammation in chronic pancreatitis are an important problem. In some cases, prevention of these acute flares of inflammation is not possible. Population-based studies and meta-analysis of randomized controlled trials suggest that statins may decrease the incidence of acute pancreatitis. SIMBA aims to investigate the effect of simvastatin on the incidence of new episodes of pancreatitis in recurrent acute pancreatitis and chronic pancreatitis. This is a non-profit, researcher-driven placebo-controlled multicenter (27 Spanish centers) randomized controlled trial
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
. Adult (\>=18) patients
. At least 2 episodes of acute pancreatitis or acute flares of chronic pancreatitis
. Written consent to participate in the study
Exclusion criteria
. \<2 episodes of pancreatitis in the last 12 months.
. Statin consumption in the previous year.
. Contraindications to the use of Statins
. Cholelithiasis or choledocholitiasis diagnosed in the last episode of pancreatitis
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.
1This trial was terminated before it finished — can you find out why it was stopped, and does that affect whether simvastatin is still considered a promising option for preventing my pancreatitis from coming back?
2Since this was a Phase 3 trial, it was already testing effectiveness in a larger group — does the fact that it was terminated mean there's incomplete safety or benefit data that I should be aware of before considering simvastatin for my condition?
3Are there any results or findings from this terminated trial that have been published or shared, and could those findings change the way you'd approach preventing my pancreatitis from recurring?
4Given that this study was specifically looking at relapsing pancreatitis, is simvastatin something you'd consider discussing as part of my treatment plan, or are there other evidence-based options that might be a better fit given where the research stands now?
5Could the termination of this trial mean there are other active studies or treatments I should be looking into for preventing repeat episodes of pancreatitis?
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.
. Endoscopic sphyncterotomy and/or cholecystectomy and/or pancreatic surgery between last episode of AP and recruitment or patients who are expected to undergo one of this techniques in less than a year.
. Serum triglycerides \>500 mg/dL without previous specific treatment before the last episode of pancreatitis, or in patients expected to have a change in their specific hypertriglyceridemia treatment in less than 1 year
. Primary hyperparathyroidism that has been operated between last episode of pancreatitis and recruitment or will be operated in less than 1 year