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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00321802
First Posted: May 4, 2006
Last Update Posted: January 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Merck Sharp & Dohme Corp.
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Anne M. Gillis, University of Calgary
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Dr. Anne M. Gillis, University of Calgary:

Primary Outcome Measures:
  • Time to first detected AF [ Time Frame: 6 Months ]

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

Enrollment: 40
Study Start Date: April 2006
Study Completion Date: December 2012
Primary Completion Date: December 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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321802


Locations
Canada, Alberta
University of Calgary, Foothills Hospital
Calgary, Alberta, Canada, T2N 4N1
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

Responsible Party: Dr. Anne M. Gillis, MD, University of Calgary
ClinicalTrials.gov Identifier: NCT00321802     History of Changes
Other Study ID Numbers: 18108
First Submitted: May 3, 2006
First Posted: May 4, 2006
Last Update Posted: January 1, 2015
Last Verified: December 2014

Keywords provided by Dr. Anne M. Gillis, 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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors