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

NCT00579098

Last updated date
Study Location
Mayo Clinic
Rochester, Minnesota, 55905, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation, Arrhythmia, Inflammation, Endothelial Dysfunction
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients > or = to 18 years of age

- Clinically indicated left atrial ablation procedure for atrial fibrillation

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Atrial Fibrillation, Arrhythmia, Inflammation, Endothelial DysfunctionThe Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation
NCT00579098
  1. Rochester, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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, MDMayo 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