The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Paul A. Friedman, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00579098
First received: December 18, 2007
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Freedom from symptomatic atrial fibrillation at 3 months. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 125
Study Start Date: December 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Lipitor (atorvastatin),80 mg daily for 90 days
Drug: Atorvistatin
80 mg daily for 90 days
Other Name: Lipitor
Placebo Comparator: 2
Placebo once daily by mouth for 90 days.
Drug: Placebo
Placebo, once daily for 90 days

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients > or = to 18 years of age
  • Clinically indicated left atrial ablation procedure for atrial fibrillation

Exclusion Criteria:

  • Exclusion criteria are known malignancy
  • Known inflammatory disease
  • Surgery or trauma or myocardial infarction in the previous month
  • Known contraindication to statin therapy
  • Elevated liver enzymes two times normal
  • Patients already receiving therapy with any statin, niacin or fibrates at the time of their randomization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579098

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Pfizer
Investigators
Principal Investigator: Paul A Friedman, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Paul A. Friedman, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00579098     History of Changes
Other Study ID Numbers: 07-005460
Study First Received: December 18, 2007
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Atrial Fibrillation
Arrhythmia
Pulmonary Vein Isolation
Left atrial catheter ablation
Inflammation
Endothelial dysfunction

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Inflammation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014