Perioperative Statin Therapy for the Prevention of Atrial Fibrillation After Anatomical Lung Resection: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- Number of Participants With New-Onset Postoperative Atrial or Supraventricular Tachyarrhythmia (Postoperative Atrial Fibrillation, POAF)
研究概览
简要总结
The goal of this clinical trial is to learn whether short-term treatment with atorvastatin can prevent new abnormal rapid heart rhythms after lung surgery in adults aged 60 years or older who are scheduled to have a lung segment or lung lobe removed. The study will also evaluate the safety of short-term atorvastatin treatment around the time of surgery.
The main questions this study aims to answer are:
- Does perioperative atorvastatin lower the number of participants who develop atrial fibrillation or a related rapid rhythm from the upper chambers of the heart during the first 72 hours after surgery?
- What medical problems or changes in liver, kidney, or muscle-related laboratory tests occur during treatment?
Participants will be assigned by chance to receive either short-term atorvastatin treatment or a matching placebo-based comparison treatment. A placebo is a look-alike tablet that does not contain atorvastatin. Participants who were already taking a statin (moderate-intensity) before the study will receive a standardized background statin regimen so that their usual treatment is not stopped unnecessarily. Neither the participants nor most members of the research team will know which treatment has been assigned.
Study treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery. After surgery, participants will wear a portable heart monitor continuously for 72 hours to identify abnormal heart rhythms. Researchers will also collect routine clinical information, blood test results, and safety information during the hospital stay and will follow participants for 30 days after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 years or older.
- •Scheduled to undergo isolated anatomical lung resection, including pulmonary segmentectomy or lobectomy.
- •Sinus rhythm documented by a preoperative electrocardiogram.
- •Not receiving antiarrhythmic medication, with the exception of beta-blockers.
- •Willing and able to provide written informed consent.
排除标准
- •Untreated hyperthyroidism or hypothyroidism.
- •History of obstructive hepatobiliary disease, active liver disease, or other serious liver disease.
- •Preoperative serum creatinine greater than 150 μmol/L.
- •Known allergy to atorvastatin or another statin, or a history of a serious statin-related adverse reaction, including statin-associated myopathy.
- •Personal or family history of an inherited muscle disorder.
- •Continuous use within 1 month before randomization of fibrates, niacin, or medications that strongly inhibit cytochrome P450 or P-glycoprotein, including cyclosporine, oral azole antifungal agents, certain interacting antibiotics, protease inhibitors, nefazodone, or amiodarone.
- •Consumption of 1 liter or more of grapefruit juice per day within 1 month before randomization.
- •Current treatment with a high-intensity statin regimen, including atorvastatin 40 mg/day or higher or rosuvastatin 20 mg/day or higher.
- •Any other condition that, in the investigator's judgment, would make participation unsafe or interfere with the conduct or evaluation of the study.
研究组 & 干预措施
Placebo-Based Comparator
Statin-naive participants/Participants receiving long-term low-intensity statin therapy will receive two matching placebo tablets orally once daily. Participants receiving long-term moderate-intensity statin therapy before enrollment will receive atorvastatin 20 mg plus one matching placebo tablet once daily. Treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery.
干预措施: Matching Placebo (Drug)
Placebo-Based Comparator
Statin-naive participants/Participants receiving long-term low-intensity statin therapy will receive two matching placebo tablets orally once daily. Participants receiving long-term moderate-intensity statin therapy before enrollment will receive atorvastatin 20 mg plus one matching placebo tablet once daily. Treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery.
干预措施: Atorvastatin (Drug)
Perioperative Atorvastatin 40 mg
Participants will receive atorvastatin 40 mg orally once daily, administered as two 20-mg tablets. Treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery.
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Number of Participants With New-Onset Postoperative Atrial or Supraventricular Tachyarrhythmia (Postoperative Atrial Fibrillation, POAF)
时间窗: From the end of surgery through 72 hours after surgery
The number of participants with at least one new electrocardiographically documented episode of atrial fibrillation, atrial flutter, atrial tachycardia, or other supraventricular tachycardia lasting at least 30 seconds. Events will be detected primarily by continuous single-lead Holter monitoring for 72 hours after surgery. Bedside electrocardiographic monitoring and 12-lead electrocardiograms will be used as additional supporting evidence. Each participant will be counted once, regardless of the number of qualifying episodes.
次要结局
未报告次要终点
研究者
Lu Tao
Principal Investigator
Peking Union Medical College Hospital