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

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ClinicalTrials.gov Identifier: NCT00756886
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : April 2, 2013
Last Update Posted : April 2, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Arrhythmia Drug: Atorvastatin Drug: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study
Study Start Date : September 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011


Arm Intervention/treatment
Active Comparator: Atorvastatin
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Drug: Atorvastatin
40 mg QD 7 day continue after procedure for 14 days
Placebo Comparator: Placebo
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Drug: Placebo
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.



Primary Outcome Measures :
  1. Atrial Fibrillation [ Time Frame: 0-21 days post-operative ]


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756886


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Pfizer
Investigators
Principal Investigator: Robert J Cerfolio, MD University of Alabama at Birmingham, Department of Surgery

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00756886     History of Changes
Other Study ID Numbers: F080722005
First Posted: September 22, 2008    Key Record Dates
Results First Posted: April 2, 2013
Last Update Posted: April 2, 2013
Last Verified: December 2012

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors