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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00611143
First received: January 27, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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 Intervention
Coronary Artery Bypass
 Drug: atorvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG [ Time Frame: in-hospital period ] [ Designated as safety issue: No ]

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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Atorvastatin group
 Drug: atorvastatin
atorvastatin 20 mg/d, started 3 days before surgery
No Intervention: 2
Control group

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Samsung Medical Center

Additional 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
Study First Received: January 27, 2008
Last Updated: January 27, 2008
Health Authority: South Korea: Institutional Review Board

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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013