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Trial record 1 of 1 for:    NCT00579098
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The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation (ATTAC)

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ClinicalTrials.gov Identifier: NCT00579098
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : April 23, 2014
Last Update Posted : April 23, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Paul A. Friedman, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE December 18, 2007
First Posted Date  ICMJE December 21, 2007
Results First Submitted Date  ICMJE April 4, 2013
Results First Posted Date  ICMJE April 23, 2014
Last Update Posted Date April 23, 2014
Study Start Date  ICMJE December 2007
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2014)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
Freedom from symptomatic atrial fibrillation at 3 months. [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2014)
  • 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.
  • Change in Mean C-Reactive Protein Level [ Time Frame: Baseline and 3 months ]
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
  • Freedom from atrial arrhythmia (as opposed to atrial fibrillation) recurrence irrespective of symptoms. [ Time Frame: 3 month ]
  • Reduction in CRP, lipid levels, and incidence of endothelial dysfunction at 3 months. [ Time Frame: 3 months ]
  • Improvement in quality of life. [ Time Frame: 3 months ]
  • Measurement of healthcare resource utilization and costs. [ Time Frame: 3 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation
Official Title  ICMJE Atorvastatin for Prevention of Atrial Fibrillation Recurrence Following Pulmonary Veins Isolation: A Double-Blind, Placebo-Controlled, Randomized Pilot Trial
Brief 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.
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. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Arrhythmia
  • Inflammation
  • Endothelial Dysfunction
Intervention  ICMJE
  • Drug: Atorvastatin
    80 mg tablet taken by mouth daily for 90 days
    Other Name: Lipitor
  • Drug: Placebo
    Placebo tablet taken by mouth once daily for 90 days
    Other Name: Placebo (dummy) tablet to match appearance of atorvastatin
Study Arms  ICMJE
  • Active Comparator: Atorvastatin
    Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: Placebo
    Placebo (dummy) tablet taken once daily by mouth for 90 days
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2007)
125
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00579098
Other Study ID Numbers  ICMJE 07-005460
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul A. Friedman, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Paul A Friedman, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP