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Completed

NCT Number: NCT00611143

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

The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.

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Key information

Conditions

Coronary Artery Bypass

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiac and Vascular Center; Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

atorvastatin 20 mg/d, started 3 days before surgery

Primary outcomes

  1. the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG

    Time frame: in-hospital period

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 8, 2008
Registry last updated
Feb 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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