The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation
To investigate whether statin therapy utilizing the drug Lipitor (atorvastatin) might be effective in preventing short-and long-term atrial fibrillation following a left atrial ablation procedure. We further hypothesize this reduction will result from diminished peri-procedural inflammation, which will be reflected in lower CRP values.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Atorvastatin for Prevention of Atrial Fibrillation Recurrence Following Pulmonary Veins Isolation: A Double-Blind, Placebo-Controlled, Randomized Pilot Trial|
- Freedom from symptomatic atrial fibrillation at 3 months. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Freedom from atrial arrhythmia (as opposed to atrial fibrillation) recurrence irrespective of symptoms. [ Time Frame: 3 month ] [ Designated as safety issue: No ]
- Reduction in CRP, lipid levels, and incidence of endothelial dysfunction at 3 months. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Improvement in quality of life. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Measurement of healthcare resource utilization and costs. [ Time Frame: 3 month ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Lipitor (atorvastatin),80 mg daily for 90 days
80 mg daily for 90 days
Other Name: Lipitor
Placebo Comparator: 2
Placebo once daily by mouth for 90 days.
Placebo, once daily for 90 days
Although pharmacologic therapy is the traditional mainstay of therapy for AF, curative therapy has recently become possible.
There is growing evidence that inflammation may be involved in the pathogenesis of AF. C-reactive protein (CRP), a sensitive marker of systemic inflammation, is increased in patients with AF compared with patients in sinus rhythm. Elevated CRP levels are associated with increased likelihood of new onset AF and with recurrence of AF after successful cardioversion. Clinical and basic laboratory evidence suggests that, in addition to being potent lipid-lowering agents, statins may also have anti-inflammatory properties and protective effect against AF.
125 eligible patients with AF, undergoing left atrial ablation, will be randomly assigned in a 1:1 ratio to receive daily 80 mg of atorvastatin or placebo in a double-blind fashion for 3 months after their ablation procedure.
Patients will have baseline lipids, CRP, endothelial function tests (PAT)and Quality of Life (QoL) surveys compared with testing at 3 months post ablation.