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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Atorvastatin

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

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

40 mg QD 7 day continue after procedure for 14 days

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Atorvastatin

40 mg QD 7 day continue after procedure for 14 days

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes