Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321802
Status:
COMPLETED
Last Update Posted:
2015-01-01
First Post:
2006-05-03
Brief Title:
Paroxysmal Atrial Fibrillation Role of Inflammation Oxidative Stress Injury and Effect of Statins
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Paroxysmal Atrial Fibrillation Role of Inflammation Oxidative Stress Injury and Effect of Statins
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAFRIOSIES
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None