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

Not Applicable

Completed

• Conditions: Arrhythmia
• Interventions: Drug: Placebo; Drug: Atorvastatin

• Registration Number: NCT00756886
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-19
• Study First Posted: 2008-09-22
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2012-05-31
• Status Verified: 2012-12
• Results First Submitted QC: 2013-02-26
• Last Update Submitted: 2013-02-26
• Results First Posted: 2013-04-02
• Last Update Posted: 2013-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Patients scheduled for elective non-cardiac thoracic surgery requiring thoracotomy for resection

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Atorvastatin	Atorvastatin	40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation	0-21 days post-operative

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States