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Sponsors and Collaborators: |
Mayo Clinic Pfizer |
Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00579098 |
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.
Condition | Intervention | Phase |
Atrial Fibrillation Arrhythmia Inflammation Endothelial Dysfunction |
Drug: Atorvistatin Drug: Placebo |
Phase IV |
Genetics Home Reference related topics: | Brugada syndrome familial atrial fibrillation short QT syndrome |
MedlinePlus related topics: | Arrhythmia |
ChemIDplus related topics: | Atorvastatin Atorvastatin calcium |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Atorvastatin for Prevention of Atrial Fibrillation Recurrence Following Pulmonary Veins Isolation: A Double-Blind, Placebo-Controlled, Randomized Pilot Trial |
Estimated Enrollment: | 125 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | January 2009 |
Arms | Assigned Interventions |
1: Active Comparator
Lipitor (atorvastatin),80 mg daily for 90 days
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Drug: Atorvistatin
80 mg daily for 90 days
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2: Placebo Comparator
Placebo once daily by mouth for 90 days.
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Drug: Placebo
Placebo, once daily for 90 days
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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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Celeste M Koestler, RN | 507-255-2200 | koestler.celeste@mayo.edu |
Contact: Diane M Batzel | 507-538-7043 | batzel.diane@mayo.edu |
United States, Minnesota | |||||
Mayo Clinic | Recruiting | ||||
Rochester, Minnesota, United States, 55905 | |||||
Contact: Celeste Koestler, RN 507-255-2200 koestler.celeste@mayo.edu | |||||
Principal Investigator: Paul A Friedman, MD |
Mayo Clinic |
Pfizer |
Principal Investigator: | Paul A Friedman, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic ( Dr. Paul Friedman ) |
Study ID Numbers: | 07-005460 |
First Received: | December 18, 2007 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00579098 |
Health Authority: | United States: Institutional Review Board |
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