Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study
Primary Purpose
Arrhythmia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Arrhythmia
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Atorvastatin
Placebo
Arm Description
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Outcomes
Primary Outcome Measures
Atrial Fibrillation
Secondary Outcome Measures
Full Information
NCT ID
NCT00756886
First Posted
September 18, 2008
Last Updated
February 26, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00756886
Brief Title
Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study
Official Title
Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
40 mg QD 7 day continue after procedure for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Primary Outcome Measure Information:
Title
Atrial Fibrillation
Time Frame
0-21 days post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Cerfolio, MD
Organizational Affiliation
University of Alabama at Birmingham, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study
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