Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm
This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00007605
First received: December 29, 2000
Last updated: June 13, 2011
Last verified: June 2011
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | CSP #399 - The Effects of Antiarrhythmic Therapy in Maintaining Stability of Sinus Rhythm in Atrial Fibrillation |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- Treatment failure, defined as occurrence of atrial fibrillation or flutter after day 28 or failure to convert to sinus rhythm. [ Time Frame: After day 28 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 706 |
| Study Start Date: | April 1998 |
| Study Completion Date: | December 2003 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Amiodarone or Sotalol
|
Drug: Amiodarone
Patients assigned will receive 400 mg bid for 14 days, 400 mg QAM and 200 mg QHS for 14 days, 300 mg qd for 48 weeks, then 200 mg qd.
|
|
Active Comparator: 2
Sotalol
|
Drug: Sotalol
Patients assigned will receive 80 mg bid for 7 days and 160 mg bid thereafter.
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who have atrial fibrillation continuously for greater than 72 hours.
Exclusion Criteria:
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007605
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Hide Study LocationsLocations
| United States, Arizona | |
| Southern Arizona VA Health Care System, Tucson | |
| Tucson, Arizona, United States, 85723 | |
| United States, Arkansas | |
| Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock | |
| No. Little Rock, Arkansas, United States, 72114-1706 | |
| United States, California | |
| VA Central California Health Care System, Fresno | |
| Fresno, California, United States, 93703 | |
| VA Medical Center, Loma Linda | |
| Loma Linda, California, United States, 92357 | |
| VA Palo Alto Health Care System | |
| Palo Alto, California, United States, 94304-1290 | |
| VA Greater Los Angeles HCS, Sepulveda | |
| Sepulveda, California, United States, 91343 | |
| VA Greater Los Angeles Healthcare System, West LA | |
| West Los Angeles, California, United States, 90073 | |
| United States, Connecticut | |
| VA Connecticut Health Care System (West Haven) | |
| West Haven, Connecticut, United States, 06516 | |
| United States, District of Columbia | |
| VA Medical Center, DC | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Florida | |
| VA Medical Center, Bay Pines | |
| Bay Pines, Florida, United States, 33708 | |
| James A. Haley Veterans Hospital, Tampa | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| VA Medical Center, Augusta | |
| Augusta, Georgia, United States, 30904 | |
| United States, Illinois | |
| Edward Hines, Jr. VA Hospital | |
| Hines, Illinois, United States, 60141-5000 | |
| United States, Iowa | |
| VA Medical Center, Iowa City | |
| Iowa City, Iowa, United States, 52246-2208 | |
| United States, Massachusetts | |
| VA Boston Healthcare System, Brockton Campus | |
| Brockton, Massachusetts, United States, 02301 | |
| United States, Minnesota | |
| VA Medical Center, Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Missouri | |
| VA Medical Center, Kansas City MO | |
| Kansas City, Missouri, United States, 64128 | |
| VA Medical Center, St Louis | |
| St Louis, Missouri, United States, 63106 | |
| United States, New Mexico | |
| New Mexico VA Health Care System, Albuquerque | |
| Albuquerque, New Mexico, United States, 87108-5153 | |
| United States, North Dakota | |
| VA Medical Center, Fargo | |
| Fargo, North Dakota, United States, 58102 | |
| United States, Oregon | |
| VA Medical Center, Portland | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| VA Pittsburgh Health Care System | |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| United States, Rhode Island | |
| VA Medical Center, Providence | |
| Providence, Rhode Island, United States, 02908 | |
| United States, Tennessee | |
| VA Medical Center, Memphis | |
| Memphis, Tennessee, United States, 38104 | |
| VA Medical Center | |
| Nashville, Tennessee, United States, 37212-2637 | |
| United States, Texas | |
| VA North Texas Health Care System, Dallas | |
| Dallas, Texas, United States, 75216 | |
| United States, Virginia | |
| Hunter Holmes McGuire VA Medical Center | |
| Richmond, Virginia, United States, 23249 | |
| United States, Wisconsin | |
| Wlliam S. Middleton Memorial Veterans Hospital, Madison | |
| Madison, Wisconsin, United States, 53705 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Bramah N. Singh | VA Greater Los Angeles Healthcare System, West LA |
More Information
Publications:
| Responsible Party: | Singh, Bramah - Study Chair, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00007605 History of Changes |
| Other Study ID Numbers: | 399 |
| Study First Received: | December 29, 2000 |
| Last Updated: | June 13, 2011 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Department of Veterans Affairs:
|
amiodarone atrial fibrillation converted to sinus rhythm cardiac mortality |
major and minor bleeds sinus rhythm sotalol |
Additional relevant MeSH terms:
|
Atrial Fibrillation Death, Sudden Cerebral Infarction Stroke Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Death Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Amiodarone Sotalol Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013