Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Atrial Fibrillation
研究概览
简要总结
The purpose of this study is to determine if atorvastatin (Lipitor) reduces the occurence of abnormal heart rhythm (atrial arrhythmia) following non cardiac thoracic surgery.
详细描述
The incidence of atrial arrhythmia after thoracic, non-cardiac procedures is exceedingly common and has been reported to occur in between 10-39% of patients. It has been shown to increase majority morbidity and also delay hospital discharge. Recent studies suggest that one week of pre-operative atorvastatin may reduce the incidence of post-operative atrial arrhythmia in patients who undergo cardiac surgery and a multi-institutional study is currently underway to further examine this concept. However, there are no published prospective randomized studies to date that have evaluated the effectiveness of atorvastatin to reduce atrial arrhythmia in patients who undergo thoracic, non-cardiac operations such as esophagectomy or pulmonary resection. The object of this study is to determine if atorvastatin reduces the incidence of atrial arrhythmia (atrial fibrillation or flutter) following non-cardiac thoracic surgery, specifically pulmonary resections.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for elective non-cardiac thoracic surgery requiring thoracotomy for resection
排除标准
- •Past medical history of pacemaker implantation
- •Pregnancy or lactating
- •History of Atrial arrhythmia within the past year
- •Elevated liver enzymes pre-operatively
- •Past medical history of any liver disease or history of liver transplantation
- •Use of statins or any anti-arrhythmics (including beta-blockers, calcium channel blockers, digoxin) within 3 months prior to surgery
- •Pre-op EKG showing atrial arrhythmia
研究组 & 干预措施
Atorvastatin
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
干预措施: Atorvastatin (Drug)
Placebo
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Atrial Fibrillation
时间窗: 0-21 days post-operative
次要结局
未报告次要终点
