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| Sponsors and Collaborators: |
University of Calgary Merck Canada Ltd. Canadian Institutes of Health Research (CIHR) |
| Information provided by: | University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00321802 |
Purpose
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.
| Condition | Intervention | Phase |
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Atrial Fibrillation |
Drug: Simvastatin Drug: Placebo |
Phase II |
| Genetics Home Reference related topics: | Brugada syndrome familial atrial fibrillation short QT syndrome |
| MedlinePlus related topics: | Stress |
| Drug Information available for: | Simvastatin |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins |
| Estimated Enrollment: | 110 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Patients randomized to active drug, then AF burden and CRP values will be compared to those in placebo arm.
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Drug: Simvastatin
Patients take 40 mg of simvastatin per day for 6 months.
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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.
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Drug: Placebo
Placebo
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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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Cynthia Chen, MSc | 403-220-2544 | jichen@ucalgary.ca |
| Contact: Anne M Gillis, MD | 403-220-6841 | amgillis@ucalgary.ca |
| Canada, Alberta | |||||
| University of Calgary, Foothills Hospital | Recruiting | ||||
| Calgary, Alberta, Canada, T2N 4N1 | |||||
| Principal Investigator: Anne M Gillis, MD | |||||
| University of Calgary |
| Merck Canada Ltd. |
| Canadian Institutes of Health Research (CIHR) |
| 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 |
More Information
| Responsible Party: | University of Calgary ( Anne M. Gillis M.D. ) |
| Study ID Numbers: | 18108 |
| First Received: | May 3, 2006 |
| Last Updated: | October 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00321802 |
| Health Authority: | Canada: Health Canada |
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