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

NCT00321802 | Completed Phase 2

• 1 other identifier: 18108
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; statin therapy; CRP levels; Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Time to first detected AF

  6 Months

Secondary Outcomes (1)

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

  6 Months

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Simvastatin

2

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Simvastatin DRUG

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

Also known as: Zocor

1

Placebo DRUG

Placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Merck Sharp & Dohme LLC: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Calgary, Foothills Hospital

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Anne M Gillis, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 3, 2006
• First Posted: May 4, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 1, 2015

Record last verified: 2014-12

Locations

CA (1)