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Cholesterol lowering with atorvastatine for the prevention of gallstones following bariatric surgery: an investigator- blinded randomised controlled trial (CHOLSTONE)
EU CTIS ID: 2025-524191-38-00
What this study is testing
To evaluate the efficacy of atorvastatin 40 mg once daily, initiated two weeks before and continued for six months after bariatric surgery, in preventing the formation of gallstones compared with standard care.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Scheduled to undergo laparoscopic Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG).
- Presence of an intact gallbladder without gallstones, confirmed by preoperative ultrasound.
- Preoperative LDL cholesterol level equal to or exceeding 2.0 mmol/L.
You likely can't join if
- Previous bariatric surgery.
- Current use of PCSK9 inhibitors, statins, ezetimibe, or fibrates.
- Known intolerance to statins.
- Presence of symptomatic or asymptomatic gallstones prior to bariatric surgery.
- Familial hypercholesterolemia.
- Severe liver disease (Child-Pugh score 10–15).
See the full eligibility criteria
- Scheduled to undergo laparoscopic Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG).
- Presence of an intact gallbladder without gallstones, confirmed by preoperative ultrasound.
- Preoperative LDL cholesterol level equal to or exceeding 2.0 mmol/L.
- Previous bariatric surgery.
- Current use of PCSK9 inhibitors, statins, ezetimibe, or fibrates.
- Known intolerance to statins.
- Presence of symptomatic or asymptomatic gallstones prior to bariatric surgery.
- Familial hypercholesterolemia.
- Severe liver disease (Child-Pugh score 10–15).
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²).
- Use of CYP3A4 inhibitors due to potential interactions with atorvastatin and increased risk of myopathy.
- Use of CYP3A4 inducers, as these may reduce plasma concentrations of atorvastatin and potentially influence the pharmacological effect of the study treatment.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.