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

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:	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: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Amiodarone hydrochloride Amidox Sotalol hydrochloride Amiodarone Sotalol

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.

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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

Show 28 Study Locations

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Study Chair:

Bramah N. Singh

VA Greater Los Angeles Healthcare System, West LA

More Information

Publications:

Singh SN, Singh BN, Reda DJ, Fye CL, Ezekowitz MD, Fletcher RD, Sharma SC, Atwood JE, Jacobson AK, Lewis HD Jr, Antman EM, Falk RH, Lopez B, Tang XC. Comparison of sotalol versus amiodarone in maintaining stability of sinus rhythm in patients with atrial fibrillation (Sotalol-Amiodarone Fibrillation Efficacy Trial [Safe-T]). Am J Cardiol. 2003 Aug 15;92(4):468-72.

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 February 12, 2012