The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation (ATTAC)
Primary Purpose
Atrial Fibrillation, Arrhythmia, Inflammation
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Arrhythmia, Pulmonary Vein Isolation, Left atrial catheter ablation, Inflammation, Endothelial dysfunction
Eligibility 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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Atorvastatin
Placebo
Arm Description
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
Placebo (dummy) tablet taken once daily by mouth for 90 days
Outcomes
Primary Outcome Measures
Percentage of Subjects Without Symptoms of Atrial Fibrillation at 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 Outcome Measures
Percentage of Subjects Without Atrial Arrhythmia at 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
Change in Mean Quality of Life Score
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
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.
Full Information
NCT ID
NCT00579098
First Posted
December 18, 2007
Last Updated
March 21, 2014
Sponsor
Mayo Clinic
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00579098
Brief Title
The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation
Acronym
ATTAC
Official Title
Atorvastatin for Prevention of Atrial Fibrillation Recurrence Following Pulmonary Veins Isolation: A Double-Blind, Placebo-Controlled, Randomized Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Arrhythmia, Inflammation, Endothelial Dysfunction
Keywords
Atrial Fibrillation, Arrhythmia, Pulmonary Vein Isolation, Left atrial catheter ablation, Inflammation, Endothelial dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (dummy) tablet taken once daily by mouth for 90 days
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
80 mg tablet taken by mouth daily for 90 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo (dummy) tablet to match appearance of atorvastatin
Intervention Description
Placebo tablet taken by mouth once daily for 90 days
Primary Outcome Measure Information:
Title
Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months
Description
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).
Time Frame
Baseline through 3 months
Secondary Outcome Measure Information:
Title
Percentage of Subjects Without Atrial Arrhythmia at 3 Months
Description
Percentage of subjects without atrial arrhythmia (as opposed to atrial fibrillation) recurrence, irrespective of symptoms. Atrial arrhythmias included AF, atrial tachycardia and atrial flutter.
Time Frame
Baseline through 3 months
Title
Change in Mean C-Reactive Protein Level
Time Frame
Baseline and 3 months
Title
Change in Mean Quality of Life Score
Description
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.
Time Frame
Baseline and 3 months
Title
Change in Lipid Levels
Description
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.
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Friedman, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
14623805
Citation
Aviles RJ, Martin DO, Apperson-Hansen C, Houghtaling PL, Rautaharju P, Kronmal RA, Tracy RP, Van Wagoner DR, Psaty BM, Lauer MS, Chung MK. Inflammation as a risk factor for atrial fibrillation. Circulation. 2003 Dec 16;108(24):3006-10. doi: 10.1161/01.CIR.0000103131.70301.4F. Epub 2003 Nov 17.
Results Reference
background
PubMed Identifier
16198844
Citation
Malouf JF, Kanagala R, Al Atawi FO, Rosales AG, Davison DE, Murali NS, Tsang TS, Chandrasekaran K, Ammash NM, Friedman PA, Somers VK. High sensitivity C-reactive protein: a novel predictor for recurrence of atrial fibrillation after successful cardioversion. J Am Coll Cardiol. 2005 Oct 4;46(7):1284-7. doi: 10.1016/j.jacc.2005.06.053.
Results Reference
background
PubMed Identifier
17000910
Citation
Patti G, Chello M, Candura D, Pasceri V, D'Ambrosio A, Covino E, Di Sciascio G. Randomized trial of atorvastatin for reduction of postoperative atrial fibrillation in patients undergoing cardiac surgery: results of the ARMYDA-3 (Atorvastatin for Reduction of MYocardial Dysrhythmia After cardiac surgery) study. Circulation. 2006 Oct 3;114(14):1455-61. doi: 10.1161/CIRCULATIONAHA.106.621763. Epub 2006 Sep 25.
Results Reference
background
PubMed Identifier
15582310
Citation
Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41. doi: 10.1016/j.jacc.2004.08.062.
Results Reference
background
PubMed Identifier
21920481
Citation
Suleiman M, Koestler C, Lerman A, Lopez-Jimenez F, Herges R, Hodge D, Bradley D, Cha YM, Brady PA, Munger TM, Asirvatham SJ, Packer DL, Friedman PA. Atorvastatin for prevention of atrial fibrillation recurrence following pulmonary vein isolation: a double-blind, placebo-controlled, randomized trial. Heart Rhythm. 2012 Feb;9(2):172-8. doi: 10.1016/j.hrthm.2011.09.016. Epub 2011 Sep 13.
Results Reference
result
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The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation
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