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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Calgary.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
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
  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:


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
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: 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 Sharp & Dohme Corp.
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:
Inflammation
Atrial Fibrillation
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Simvastatin
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 September 18, 2014