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

Coronary Artery Bypass Clinical Trial

Official title:

The Effects of Atorvastatin on the Occurrence of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611143
• Other study ID #: 2006-08-022
• Status: Completed
• Phase: N/A
• First received: January 27, 2008
• Last updated: January 27, 2008
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: January 2008
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: May 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Bypass

Intervention

Drug:
• atorvastatin
atorvastatin 20 mg/d, started 3 days before surgery

Locations

Country	Name	City	State
Korea, Republic of	Cardiac and Vascular Center; Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG		in-hospital period	No
Secondary	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	No