The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation (ATTAC)
To investigate whether statin therapy utilizing the drug Lipitor (atorvastatin) might be effective in preventing short-and long-term atrial fibrillation (AF) following a left atrial ablation procedure. We further hypothesize this reduction will result from diminished peri-procedural inflammation, which will be reflected in lower C-Reactive Protein (CRP) values in the blood.
|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|
- Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months [ Time Frame: Baseline through 3 months ] [ Designated as safety issue: No ]Asymptomatic recurrence was defined as any atrial arrhythmia lasting more than 30 seconds. This was assessed by an electrocardiogram (ECG) and 72-hour Holter monitor recordings. At the end of the study, 336 ECG and Holter recordings were available for analysis (172 in the atorvastatin group and 164 in the placebo group).
- Percentage of Subjects Without Atrial Arrhythmia at 3 Months [ Time Frame: Baseline through 3 months ] [ Designated as safety issue: No ]Percentage of subjects without atrial arrhythmia (as opposed to atrial fibrillation) recurrence, irrespective of symptoms. Atrial arrhythmias included AF, atrial tachycardia and atrial flutter.
- Change in Mean C-Reactive Protein Level [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
- Change in Mean Quality of Life Score [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]A visual analogue scale (VAS) was used to collect the subject's perception of their current state of health/quality of life. The VAS consists of a vertical 20 centimeter scored line (like a thermometer) with the ends labelled best imaginable health state at the top (100) and worst imaginable health state at the bottom (0). The subject marked a single line to grade his/her own current level of function at the baseline visit and again at the 3 month visit. The average change in VAS score from baseline to 3 months later is reported for each treatment group.
- Change in Lipid Levels [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]The change from baseline to 3 months in blood cholesterol levels (total cholesterol, LDL or low-density lipoprotein and HDL or high-density lipoprotein) was calculated.
|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: Atorvastatin
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
80 mg tablet taken by mouth daily for 90 days
Other Name: Lipitor
Placebo Comparator: Placebo
Placebo (dummy) tablet taken once daily by mouth for 90 days
Placebo tablet taken by mouth once daily for 90 days
Other Name: Placebo (dummy) tablet to match appearance of atorvastatin
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. 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 and Quality of Life (QoL) surveys compared with testing at 3 months post ablation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579098
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Paul A Friedman, MD||Mayo Clinic|