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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00756886
First received: September 18, 2008
Last updated: February 26, 2013
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Arrhythmia
 Drug: Atorvastatin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Atrial Fibrillation [ Time Frame: 0-21 days post-operative ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: September 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00756886     History of Changes
Other Study ID Numbers: F080722005
Study First Received: September 18, 2008
Results First Received: May 31, 2012
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013