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

The University of Alabama at Birmingham

Status: Completed

Conditions: Arrhythmia

Treatments: Drug: Placebo; Drug: Atorvastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00756886

F080722005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 2 patient groups, including a placebo group

Atorvastatin

Active Comparator group

Description:

40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.

Treatment:

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.

Treatment:

Drug: Placebo