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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00007605 |
Purpose
Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of the latter occurring annually in patients with atrial fibrillation. The safety of the most widely used antiarrhythmic agent for this group of patients, quinidine, has been called into question. This study seeks to determine whether two other agents, amiodarone and sotalol, are safe and effective treatments for patients with atrial fibrillation.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Cerebrovascular Accident Death, Sudden |
Drug: Amiodarone Drug: Sotalol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | The Effects of Antiarrhythmic Therapy in Maintaining Stability of Sinus Rhythm in Atrial Fibrillation |
| Estimated Enrollment: | 706 |
| Study Start Date: | April 1998 |
| Estimated Study Completion Date: | September 2002 |
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- Patients who have atrial fibrillation continuously for greater than 72 hours.
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Vamc - Tucson, Az | |
| Tucson, Arizona, United States, 85723 | |
| United States, Arkansas | |
| Vamc - Little Rock, Ar | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Vamc - West Los Angeles | |
| West Los Angeles, California, United States, 90073 | |
| Vamc - Fresno, Ca | |
| Fresno, California, United States, 93703 | |
| Vamc - West Los Angeles, Ca | |
| West Los Angeles, California, United States, 90073 | |
| Vamc - Palo Alto, Ca | |
| Palo Alto, California, United States, 94304 | |
| Vamc - Sepulveda, Ca | |
| Sepulveda, California, United States, 91343 | |
| Vamc - Loma Linda, Ca | |
| Loma Linda, California, United States, 92354 | |
| United States, Connecticut | |
| Vamc - West Haven, Ct | |
| West Haven, Connecticut, United States, 06516 | |
| United States, District of Columbia | |
| Vamc - Washington, Dc | |
| Washington, District of Columbia, United States, 20422 | |
| Vamc - Washington, Dc | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Florida | |
| Vamc - Bay Pines, Fl | |
| Bay Pines, Florida, United States, 33504 | |
| Vamc - Tampa, Fl | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Vamc - Augusta, Ga | |
| Augusta, Georgia, United States, 30904 | |
| United States, Illinois | |
| Vamc - Hines, Il | |
| Hines, Illinois, United States, 60141-5000 | |
| United States, Iowa | |
| Vamc - Iowa City, Ia | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Massachusetts | |
| Vamc - Brockton (West Roxbury), Ma | |
| West Roxbury, Massachusetts, United States, 02132 | |
| United States, Minnesota | |
| Vamc - Minneapolis, Mn | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Missouri | |
| Vamc - Kansas City, Mo | |
| Kansas City, Missouri, United States, 64128 | |
| Vamc - St. Louis, Mo | |
| St. Louis, Missouri, United States, 63106 | |
| United States, New Mexico | |
| Vamc - Albuquerque, nm | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, North Dakota | |
| Vamc - Fargo, Nd | |
| Fargo, North Dakota, United States, 58102 | |
| United States, Oregon | |
| Vamc - Portland, or | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| Vamc - Pittsburgh, Pa | |
| Pittsburgh, Pennsylvania, United States, 15213-2582 | |
| Vamc - Pittsburgh, Pa | |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| United States, Rhode Island | |
| Vamc - Providence, Ri | |
| Providence, Rhode Island, United States, 02908-4799 | |
| United States, Tennessee | |
| Vamc - Memphis, Tn | |
| Memphis, Tennessee, United States, 38104 | |
| Vamc - Nashville, Tn | |
| Nashville, Tennessee, United States, 37212 | |
| Vamc - Nashville, Tn | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Vamc - Dallas, Tx | |
| Dallas, Texas, United States, 75216 | |
| United States, Virginia | |
| Vamc - Richmond, Va | |
| Richmond, Virginia, United States, 23249 | |
| Vamc - Richmond, Va | |
| Richmond, Virginia, United States, 23249 | |
| United States, Wisconsin | |
| Vamc - Madison, Wi | |
| Madison, Wisconsin, United States, 53705 | |
More Information
| Study ID Numbers: | 399 |
| Study First Received: | December 29, 2000 |
| Last Updated: | January 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00007605 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
sinus rhythm amiodarone sotalol |
atrial fibrillation converted to sinus rhythm major and minor bleeds cardiac mortality |
|
Neurotransmitter Agents Death Vasodilator Agents Adrenergic Agents Cerebral Infarction Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Brain Diseases Cerebrovascular Disorders Pathologic Processes Therapeutic Uses Adrenergic beta-Antagonists Brain Ischemia Cardiovascular Diseases Anti-Arrhythmia Agents |
Sympatholytics Heart Diseases Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Enzyme Inhibitors Cardiovascular Agents Amiodarone Pharmacologic Actions Sotalol Autonomic Agents Death, Sudden Adrenergic Antagonists Peripheral Nervous System Agents |
