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

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: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Arrhythmia
Inflammation
Endothelial Dysfunction
Drug: Atorvastatin
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:
  • Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months [ Time Frame: Baseline through 3 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percentage of Subjects Without Atrial Arrhythmia at 3 Months [ Time Frame: Baseline through 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in Mean Quality of Life Score [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


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: Atorvastatin
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
Drug: Atorvastatin
80 mg tablet taken by mouth daily for 90 days
Other Name: Lipitor
Placebo Comparator: Placebo
Placebo (dummy) tablet taken once daily by mouth for 90 days
Drug: Placebo
Placebo tablet taken by mouth once daily for 90 days
Other Name: Placebo (dummy) tablet to match appearance of atorvastatin

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.

  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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: April 4, 2013
Last Updated: March 21, 2014
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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014