Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study
1 other identifier
interventional
73
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 18, 2008
CompletedFirst Posted
Study publicly available on registry
September 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
April 2, 2013
CompletedApril 2, 2013
December 1, 2012
2.7 years
September 18, 2008
May 31, 2012
February 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Atrial Fibrillation
0-21 days post-operative
Study Arms (2)
Atorvastatin
ACTIVE COMPARATOR40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Placebo
PLACEBO COMPARATOR40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Interventions
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Eligibility Criteria
You may qualify if:
- Patients scheduled for elective non-cardiac thoracic surgery requiring thoracotomy for resection
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Pfizercollaborator
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ayesha S. Bryant, MD
- Organization
- Surgery - Cardiovascular/Thoracic
Study Officials
- PRINCIPAL INVESTIGATOR
Robert J Cerfolio, MD
University of Alabama at Birmingham, Department of Surgery
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2008
First Posted
September 22, 2008
Study Start
September 1, 2008
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
April 2, 2013
Results First Posted
April 2, 2013
Record last verified: 2012-12