Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins (PAFRIOSIES)
The purpose of this study is to determine the effect of statin therapy for prevention of atrial fibrillation (AF) in pacemaker and non-pacemaker patients with paroxysmal atrial fibrillation in the absence of significant coronary artery disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins|
- Time to first detected AF [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- Changes in CRP and oxidative stress levels over time and their relationship with AF burden [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2006|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Patients randomized to active drug, then AF burden and CRP values will be compared to those in placebo arm.
Patients take 40 mg of simvastatin per day for 6 months.
Other Name: Zocor
Placebo Comparator: 2
Patients take placebo once daily for 6 Months, then AF burden and CRP values will be compared to those in experimental arm.
Other Name: Placebo
Patients with a history of paroxysmal atrial fibrillation, with or without a dual chamber pacemaker and who meet all study criteria, will be randomized to receive either a placebo, or simvastatin 40 mg, daily for 6 months.
Liver enzymes are drawn at randomization and 3 months. CRP and oxidative stress products are drawn at randomization, weekly for the first month and then monthly for 5 months.
Patients transmit their rhythm, twice daily for 5 consecutive days at randomization, then 5 consecutive days monthly for 6 months.
Clinic visits are required at randomization, 3 months and 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321802
|University of Calgary, Foothills Hospital|
|Calgary, Alberta, Canada, T2N 4N1|
|Principal Investigator:||Anne M Gillis, MD||University of Calgary|
|Study Director:||Henry J Duff, MD||University of Calgary|
|Study Director:||Derek V Exner, MD, MPH||University of Calgary|
|Study Director:||Katherine Kavanagh, MD||University of Calgary|
|Study Director:||L B Mitchell, MD||University of Calgary|
|Study Director:||Robert S Sheldon, MD, PhD||University of Calgary|
|Study Director:||D G Wyse, MD, PhD||University of Calgary|
|Study Director:||George Veenhuyzen, MD||University of Calgary|