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

December 30, 2014 updated by: Dr. Anne M. Gillis, University of Calgary
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first detected AF
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in CRP and oxidative stress levels over time and their relationship with AF burden
Time Frame: 6 Months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Merck Sharp & Dohme LLC
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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 3, 2006

First Submitted That Met QC Criteria

May 3, 2006

First Posted (Estimate)

May 4, 2006

Study Record Updates

Last Update Posted (Estimate)

January 1, 2015

Last Update Submitted That Met QC Criteria

December 30, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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