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

Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756886
• Other study ID #: F080722005
• Status: Completed
• Phase: N/A
• First received: September 18, 2008
• Last updated: February 26, 2013
• Start date: September 2008
• Est. completion date: May 2011

Study information

• Verified date: December 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation

Intervention

Drug:
• Atorvastatin
40 mg QD 7 day continue after procedure for 14 days
• Placebo
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial Fibrillation		0-21 days post-operative	No