Atorvastatin for Prevention of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery
Primary Purpose
Coronary Artery Bypass
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
atorvastatin
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Bypass focused on measuring Off-pump coronary artery bypass graft, Atorvastatin, Postoperative atrial fibrillation
Eligibility Criteria
Inclusion Criteria:
- consecutive patients scheduled for the elective off-pump CABG surgery
Exclusion Criteria:
- prior statin use
- previous episodes of atrial fibrillation
- impaired renal function with serum creatinine >2mg/dL
- serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
- a malignancy or inflammatory disease
Sites / Locations
- Cardiac and Vascular Center; Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Atorvastatin group
Control group
Outcomes
Primary Outcome Measures
the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG
Secondary Outcome Measures
major adverse cardiac and cerebrovascular events rate, including cardiovascular death, postoperative stroke, myocardial infarction, or persistent atrial fibrillation,and identification of predictive markers for postoperative atrial fibrillation
Full Information
NCT ID
NCT00611143
First Posted
January 27, 2008
Last Updated
January 27, 2008
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00611143
Brief Title
Atorvastatin for Prevention of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery
Official Title
The Effects of Atorvastatin on the Occurrence of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.
Detailed Description
Atrial fibrillation after cardiac surgery is the most common arrhythmic complication that may increase incidence of congestive heart failure, renal insufficiency, and stroke, which increase the length of hospital stay, the rates of re-hospitalization, and cost of care. Its pathogenesis is multifactorial, and its prevention and management remain suboptimal. Recently, observational evidence has suggested that patients who have undergone previous statin therapy have a lower incidence of postoperative atrial fibrillation.
The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass
Keywords
Off-pump coronary artery bypass graft, Atorvastatin, Postoperative atrial fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Atorvastatin group
Arm Title
2
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
atorvastatin 20 mg/d, started 3 days before surgery
Primary Outcome Measure Information:
Title
the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG
Time Frame
in-hospital period
Secondary Outcome Measure Information:
Title
major adverse cardiac and cerebrovascular events rate, including cardiovascular death, postoperative stroke, myocardial infarction, or persistent atrial fibrillation,and identification of predictive markers for postoperative atrial fibrillation
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
consecutive patients scheduled for the elective off-pump CABG surgery
Exclusion Criteria:
prior statin use
previous episodes of atrial fibrillation
impaired renal function with serum creatinine >2mg/dL
serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
a malignancy or inflammatory disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Keun On, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiac and Vascular Center; Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
18657672
Citation
Song YB, On YK, Kim JH, Shin DH, Kim JS, Sung J, Lee SH, Kim WS, Lee YT. The effects of atorvastatin on the occurrence of postoperative atrial fibrillation after off-pump coronary artery bypass grafting surgery. Am Heart J. 2008 Aug;156(2):373.e9-16. doi: 10.1016/j.ahj.2008.04.020. Epub 2008 Jun 17.
Results Reference
derived
Learn more about this trial
Atorvastatin for Prevention of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery
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