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

NCT ID: NCT00321802

Last Updated: 2015-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2012-12-31

Brief 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.

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Patients randomized to active drug, then AF burden and CRP values will be compared to those in placebo arm.

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

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

2

Patients take placebo once daily for 6 Months, then AF burden and CRP values will be compared to those in experimental arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Simvastatin

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

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Zocor

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dr. Anne M. Gillis

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne M Gillis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Henry J Duff, MD

Role: STUDY_DIRECTOR

University of Calgary

Derek V Exner, MD, MPH

Role: STUDY_DIRECTOR

University of Calgary

Katherine Kavanagh, MD

Role: STUDY_DIRECTOR

University of Calgary

L B Mitchell, MD

Role: STUDY_DIRECTOR

University of Calgary

Robert S Sheldon, MD, PhD

Role: STUDY_DIRECTOR

University of Calgary

D G Wyse, MD, PhD

Role: STUDY_DIRECTOR

University of Calgary

George Veenhuyzen, MD

Role: STUDY_DIRECTOR

University of Calgary

Locations

University of Calgary, Foothills Hospital

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

18108

Identifier Type: -

Identifier Source: org_study_id