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.
Information provided by:
VA Office of Research and Development Identifier:
First received: December 29, 2000
Last updated: June 13, 2011
Last verified: June 2011
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:

Further study details as provided by VA Office of Research and Development:

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
Drug: Sotalol
Patients assigned will receive 80 mg bid for 7 days and 160 mg bid thereafter.

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Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00007605

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Sponsors and Collaborators
VA Office of Research and Development
Study Chair: Bramah N. Singh VA Greater Los Angeles Healthcare System, West LA
  More Information

Responsible Party: Singh, Bramah - Study Chair, Department of Veterans Affairs 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 VA Office of Research and Development:
atrial fibrillation converted to sinus rhythm
cardiac mortality
major and minor bleeds
sinus rhythm

Additional relevant MeSH terms:
Atrial Fibrillation
Death, Sudden
Arrhythmias, Cardiac
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Heart Diseases
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Autonomic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents processed this record on May 26, 2016