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
  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:


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
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 ClinicalTrials.gov identifier: NCT00007605

  Show 28 Study Locations
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
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014