Skip to main content
OpenTrials
Completed

NCT Number: NCT00756886

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

40 mg QD 7 day continue after procedure for 14 days

Placebo

Drug

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

Primary outcomes

  1. Atrial Fibrillation

    Time frame: 0-21 days post-operative

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 22, 2008
Registry last updated
Apr 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.