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

NCT00579098 | Completed Phase 4 Results

• 1 other identifier: 07-005460
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Arrhythmia; Inflammation; Endothelial Dysfunction

Keywords

Atrial Fibrillation; Arrhythmia; Pulmonary Vein Isolation; Left atrial catheter ablation; Inflammation; Endothelial dysfunction

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline through 3 months

Secondary Outcomes (4)

• Percentage of Subjects Without Atrial Arrhythmia at 3 Months

  Baseline through 3 months

• Change in Mean C-Reactive Protein Level

  Baseline and 3 months

• Change in Mean Quality of Life Score

  Baseline and 3 months

• Change in Lipid Levels

  Baseline and 3 months

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

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

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Atorvastatin DRUG

80 mg tablet taken by mouth daily for 90 days

Also known as: Lipitor

Atorvastatin

Placebo DRUG

Placebo tablet taken by mouth once daily for 90 days

Also known as: Placebo (dummy) tablet to match appearance of atorvastatin

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> or = to 18 years of age
• Clinically indicated left atrial ablation procedure for atrial fibrillation

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Pfizer: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (5)

• 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.

  PMID: 14623805 BACKGROUND

• 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.

  PMID: 16198844 BACKGROUND

• 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.

  PMID: 17000910 BACKGROUND

• 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.

  PMID: 15582310 BACKGROUND

• 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.

  PMID: 21920481 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Inflammation

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Limitations and Caveats

The population was restricted to patients who did not have an indication for statin treatment. The lack of transtelephonic or prolonged Holter monitoring likely resulted in underestimation of the rate of asymptomatic episodes of AF.

Results Point of Contact

• Title: Paul A. Friedman, MD
• Organization: Mayo Clinic

friedman.paul@mayo.edu

507-255-2398

Study Officials

• Paul A Friedman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 21, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 23, 2014
• Results First Posted: April 23, 2014

Record last verified: 2014-03

Locations

US (1)