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Completed

NCT Number: NCT00321802

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Calgary, Foothills Hospital

Calgary, Alberta, T2N 4N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

Patients take 40 mg of simvastatin per day for 6 months.

Other names: Zocor

Placebo

Drug

Placebo

Primary outcomes

  1. Time to first detected AF

    Time frame: 6 Months

Secondary outcomes

  1. Changes in CRP and oxidative stress levels over time and their relationship with AF burden

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Merck Sharp & Dohme LLC

Registry information

Acronym: PAFRIOSIES

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
May 4, 2006
Registry last updated
Jan 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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