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Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins (PAFRIOSIES)

This study is currently recruiting participants.
Verified December 2011 by University of Calgary
Sponsor:
Collaborators:
Merck
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Anne M. Gillis, University of Calgary
ClinicalTrials.gov Identifier:
NCT00321802
First received: May 3, 2006
Last updated: December 19, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study is to determine the effect of statin therapy for prevention of atrial fibrillation (AF) in pacemaker and non-pacemaker patients with paroxysmal atrial fibrillation in the absence of significant coronary artery disease.


Condition Intervention Phase
Atrial Fibrillation
 Drug: Simvastatin
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins

Resource links provided by NLM:

Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Time to first detected AF [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in CRP and oxidative stress levels over time and their relationship with AF burden [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: April 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients randomized to active drug, then AF burden and CRP values will be compared to those in placebo arm.
 Drug: Simvastatin
Patients take 40 mg of simvastatin per day for 6 months.
Other Name: Zocor
Placebo Comparator: 2
Patients take placebo once daily for 6 Months, then AF burden and CRP values will be compared to those in experimental arm.
 Drug: Placebo
Placebo
Other Name: Placebo

Detailed Description:

Patients with a history of paroxysmal atrial fibrillation, with or without a dual chamber pacemaker and who meet all study criteria, will be randomized to receive either a placebo, or simvastatin 40 mg, daily for 6 months.

Liver enzymes are drawn at randomization and 3 months. CRP and oxidative stress products are drawn at randomization, weekly for the first month and then monthly for 5 months.

Patients transmit their rhythm, twice daily for 5 consecutive days at randomization, then 5 consecutive days monthly for 6 months.

Clinic visits are required at randomization, 3 months and 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with paroxysmal AF (> 3 epis each > 15 min in length) over 6 months
  • Patients on stable antiarrhythmic drug therapy and life expectancy > 1 year

Exclusion Criteria:

  • Patients with PAF due to reversible cause
  • Chronic inflammatory conditions
  • Other medical conditions requiring statin therapy
  • Patients on amiodarone or verapamil
  • Elevated CK or ALT
  • Life expectancy <1 year
  • TAVN ablation
  • Geographic isolation
  • Inability to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321802

Contacts
Contact: Heather J Mathison, BSc 403-220-8235 mathison@ucalgary.ca
Contact: Anne M Gillis, MD 403-220-6841 amgillis@ucalgary.ca

Locations
Canada, Alberta
University of Calgary, Foothills Hospital Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact: Heather Mathison, BSc     (403)220-8235     mathison@ucalgary.ca    
Principal Investigator: Anne M Gillis, MD            
Sponsors and Collaborators
University of Calgary
Merck
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Anne M Gillis, MD University of Calgary
Study Director: Henry J Duff, MD University of Calgary
Study Director: Derek V Exner, MD, MPH University of Calgary
Study Director: Katherine Kavanagh, MD University of Calgary
Study Director: L B Mitchell, MD University of Calgary
Study Director: Robert S Sheldon, MD, PhD University of Calgary
Study Director: D G Wyse, MD, PhD University of Calgary
Study Director: George Veenhuyzen, MD University of Calgary
  More Information

No publications provided

Responsible Party: Dr. Anne M. Gillis, MD, University of Calgary
ClinicalTrials.gov Identifier: NCT00321802     History of Changes
Other Study ID Numbers: 18108
Study First Received: May 3, 2006
Last Updated: December 19, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
atrial fibrillation
statin therapy
CRP levels
Paroxysmal Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Inflammation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Simvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013