Status:
COMPLETED
Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Canadian Institutes of Health Research (CIHR)
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 abs...
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 m...
Eligibility Criteria
Inclusion
- Patients with paroxysmal AF (\> 3 epis each \> 15 min in length) over 6 months
- Patients on stable antiarrhythmic drug therapy and life expectancy \> 1 year
Exclusion
- Patients with PAF due to reversible cause
- Chronic inflammatory conditions
- Other medical conditions requiring statin therapy
- Patients on amiodarone or verapamil
- Elevated CK or ALT
- Life expectancy \<1 year
- TAVN ablation
- Geographic isolation
- Inability to give informed consent
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00321802
Start Date
April 1 2006
End Date
December 1 2012
Last Update
January 1 2015
Active Locations (1)
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1
University of Calgary, Foothills Hospital
Calgary, Alberta, Canada, T2N 4N1