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| Sponsors and Collaborators: |
Emory University Pfizer |
|---|---|
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00252967 |
Purpose
The purpose of this study is to test whether the drug, atorvastatin, will be able to reduce the rate of return of the abnormal beats after using cardioversion. Atorvastatin is a drug approved by the Food and Drug Administration (FDA) for the treatment of high cholesterol but is not approved for preventing abnormal heartbeats. In addition to lowering cholesterol, the drug reduces inflammation. Inflammation seems to help cause atrial fibrillation, a certain type of abnormal heartbeat. In animals, atorvastatin reduces the risk of this type of abnormal beats, and preliminary data in humans supports an effect of atorvastatin and other similar drugs that have the same action on reducing the risk of this type of abnormal beats. We, the researchers at Emory University, would like to learn if this drug could prevent the return of these abnormal heartbeats.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Inflammation |
Drug: 80 mg daily of atorvastatin |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Atorvastatin Therapy for the Prevention of Atrial Fibrillation (SToP-AF) |
| Estimated Enrollment: | 258 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | May 2007 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Irfan Shukrullah | 404-778-2486 | ishukru@emory.edu |
| Contact: Jose R Cuellar | 404-376-1818 | jorocusi@hotmail.com |
| United States, Georgia | |
| The Emory Clinic | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Irfan Shukrullah 404-778-2486 ishukru@emory.edu | |
| Principal Investigator: Samuel C Dudley, Jr., MD, PhD | |
| Crawford Long Hospital | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Jose R Cuellar 404-376-1818 jorocusi@hotmail.com | |
| Veteran Administration Medical Center/Emory University | Recruiting |
| Atlanta, Georgia, United States, 30033 | |
| Contact: Irfan Shukrullah 404-321-6111 ext 6190 ishukru@emory.edu | |
| Contact: Jose R Cuellar 404-321-6111 ext 6190 jorocusi@hotmail.com | |
| Principal Investigator: Samuel C. Dudley, Jr., Md, PhD | |
| Principal Investigator: | Samuel D. Dudley, Jr., MD, PhD | Veterans Administration Medical Center |
More Information
| Study ID Numbers: | 1137-2004 |
| Study First Received: | November 14, 2005 |
| Last Updated: | April 10, 2007 |
| ClinicalTrials.gov Identifier: | NCT00252967 |
| Health Authority: | United States: Food and Drug Administration |
|
Reactive Oxgen Speers Atrial Fibrillation Oxidative Stress Inflammation |
|
Heart Diseases Stress Atrial Fibrillation |
Atorvastatin Arrhythmias, Cardiac Inflammation |
|
Antimetabolites Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |
