Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins (PAFRIOSIES)
|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.
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|