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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
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arrhythmia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
September 18, 2008
Last Updated
February 26, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
Pfizer
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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

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

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