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临床试验/NCT00756886
NCT00756886已完成不适用

Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Placebo Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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