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Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00007605
Recruitment Status : Completed
First Posted : January 1, 2001
Last Update Posted : June 15, 2011
Sponsor:
Information provided by:
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Cerebrovascular Accident Death, Sudden Drug: Amiodarone Drug: Sotalol Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 706 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: CSP #399 - The Effects of Antiarrhythmic Therapy in Maintaining Stability of Sinus Rhythm in Atrial Fibrillation
Study Start Date : April 1998
Actual Primary Completion Date : October 2002
Actual Study Completion Date : December 2003


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have atrial fibrillation continuously for greater than 72 hours.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007605


Locations
Show Show 28 study locations
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Study Chair: Bramah N. Singh VA Greater Los Angeles Healthcare System, West LA

Publications of Results:
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Responsible Party: Singh, Bramah - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00007605    
Other Study ID Numbers: 399
First Posted: January 1, 2001    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: June 2011
Keywords provided by VA Office of Research and Development:
amiodarone
atrial fibrillation converted to sinus rhythm
cardiac mortality
major and minor bleeds
sinus rhythm
sotalol
Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Death, Sudden
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Death
Amiodarone
Sotalol
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents