Atorvastatin for Prevention of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery

Not Applicable

Completed

• Conditions: Coronary Artery Bypass
• Interventions: Drug: atorvastatin

• Registration Number: NCT00611143
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2007-04
• Study Completion: 2007-05
• Status Verified: 2008-01
• Study First Submitted: 2008-01-27
• Study First Submitted QC: 2008-01-27
• Last Update Submitted: 2008-01-27
• Study First Posted: 2008-02-08
• Last Update Posted: 2008-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	atorvastatin	Atorvastatin group

Primary Outcome Measures

Name	Time	Method
the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG	in-hospital period

Secondary Outcome Measures

Name	Time	Method
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	30 days

Trial Locations

Locations (1)

Cardiac and Vascular Center; Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of