2025-524191-38-00招募中4 期
Cholesterol lowering with atorvastatine for the prevention of gallstones following bariatric surgery (CHOLSTONE): an investigator- blinded randomised controlled trial
Spaarne Gasthuis Stichting1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2026年3月1日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Incidence of gallstone formation six months after bariatric surgery, confirmed by ultrasound examination.
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Cholstone Trial
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ATORVASTATIN
Test
干预措施: ATORVASTATIN (Drug)
结局指标
主要结局
Incidence of gallstone formation six months after bariatric surgery, confirmed by ultrasound examination.
Incidence of gallstone formation six months after bariatric surgery, confirmed by ultrasound examination.
次要结局
- Change in plasma LDL-cholesterol levels between baseline and six months after bariatric surgery.
- Change in fecal and plasma bile acid profiles between baseline and six months after bariatric surgery.
- Incidence and severity of adverse events related to atorvastatin in the post- bariatric population
研究者
Victor Gerdes (PI)
Scientific
Spaarne Gasthuis Stichting
研究点 (1)
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