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OpenTrials
Completed

NCT Number: NCT00579098

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

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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Key information

Conditions

Atrial Fibrillation Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Endothelial Dysfunction Heart Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

80 mg tablet taken by mouth daily for 90 days

Other names: Lipitor

Placebo

Drug

Placebo tablet taken by mouth once daily for 90 days

Other names: Placebo (dummy) tablet to match appearance of atorvastatin

Primary outcomes

  1. Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months

    Time frame: Baseline through 3 months

    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).

Secondary outcomes

  1. Percentage of Subjects Without Atrial Arrhythmia at 3 Months

    Time frame: Baseline through 3 months

    Percentage of subjects without atrial arrhythmia (as opposed to atrial fibrillation) recurrence, irrespective of symptoms. Atrial arrhythmias included AF, atrial tachycardia and atrial flutter.

  2. Change in Mean C-Reactive Protein Level

    Time frame: Baseline and 3 months

  3. Change in Mean Quality of Life Score

    Time frame: Baseline and 3 months

    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.

  4. Change in Lipid Levels

    Time frame: Baseline and 3 months

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Pfizer

Registry information

Official study title

Atorvastatin for Prevention of Atrial Fibrillation Recurrence Following Pulmonary Veins Isolation: A Double-Blind, Placebo-Controlled, Randomized Pilot Trial

Acronym: ATTAC

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Dec 21, 2007
Registry last updated
Apr 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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