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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients randomized to active drug, then AF burden and CRP values will be compared to those in placebo arm. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | Patients take 40 mg of simvastatin per day for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first detected AF | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in CRP and oxidative stress levels over time and their relationship with AF burden | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary, Foothills Hospital | Calgary | Alberta | T2N 4N1 | Canada |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | Placebo |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |