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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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. 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.

Conditions

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Atrial Fibrillation Arrhythmia Inflammation Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Atorvastatin

Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

80 mg tablet taken by mouth daily for 90 days

Placebo

Placebo (dummy) tablet taken once daily by mouth for 90 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet taken by mouth once daily for 90 days

Interventions

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Atorvastatin

80 mg tablet taken by mouth daily for 90 days

Intervention Type DRUG

Placebo

Placebo tablet taken by mouth once daily for 90 days

Intervention Type DRUG

Other Intervention Names

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Lipitor Placebo (dummy) tablet to match appearance of atorvastatin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No