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

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ClinicalTrials.gov Identifier: NCT00611143
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : February 8, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Drug: atorvastatin Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effects of Atorvastatin on the Occurrence of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery
Study Start Date : May 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : May 2007


Arm Intervention/treatment
Experimental: 1
Atorvastatin group
Drug: atorvastatin
atorvastatin 20 mg/d, started 3 days before surgery
No Intervention: 2
Control group



Primary Outcome Measures :
  1. the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG [ Time Frame: in-hospital period ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611143


Locations
Korea, Republic of
Cardiac and Vascular Center; Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Young Keun On, MD, PhD Samsung Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: YK On, MD, PhD / Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00611143     History of Changes
Other Study ID Numbers: 2006-08-022
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: February 8, 2008
Last Verified: January 2008

Keywords provided by Samsung Medical Center:
Off-pump coronary artery bypass graft
Atorvastatin
Postoperative atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors