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 range18 Years
SexALL
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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
✕. 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