Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins (PAFRIOSIES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00321802|
Recruitment Status : Completed
First Posted : May 4, 2006
Last Update Posted : January 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Simvastatin Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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.
- Time to first detected AF [ Time Frame: 6 Months ]
- Changes in CRP and oxidative stress levels over time and their relationship with AF burden [ Time Frame: 6 Months ]
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): 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|