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

Atrial Fibrillation Clinical Trial

— PAFRIOSIES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321802
• Other study ID #: 18108
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2006
• Last updated: December 30, 2014
• Start date: April 2006
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Simvastatin
Patients take 40 mg of simvastatin per day for 6 months.
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	University of Calgary, Foothills Hospital	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Canadian Institutes of Health Research (CIHR), Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first detected AF		6 Months	Yes
Secondary	Changes in CRP and oxidative stress levels over time and their relationship with AF burden		6 Months	Yes