Phase 4
N=125
The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation
Atrial Fibrillation · Arrhythmia · Inflammation · Endothelial Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00579098 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months — 95; 93.5 Percentage of subjects — p=0.75
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atorvastatin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months |
95; 93.5 | 0.75 |
| SECONDARY Percentage of Subjects Without Atrial Arrhythmia at 3 Months |
85; 88 | 0.37 |
| SECONDARY Change in Mean C-Reactive Protein Level |
-0.75; 2.1 | 0.11 |
| SECONDARY Change in Mean Quality of Life Score |
13; 11 | 0.53 |
| SECONDARY Change in Lipid Levels |
-50; 15; -47; 9; 3; 3 | <0.001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients > or = to 18 years of age
- Clinically indicated left atrial ablation procedure for atrial fibrillation
Exclusion Criteria
- Known malignancy
- Known inflammatory disease
- Surgery or trauma or myocardial infarction in the previous month
- Known contraindication to statin therapy
- Elevated liver enzymes above two times the upper limit of normal
- Patients already receiving therapy with any statin, niacin or fibrates at the time of their randomization
Data sourced from ClinicalTrials.gov (NCT00579098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.