Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm
CSP #399 - The Effects of Antiarrhythmic Therapy in Maintaining Stability of Sinus Rhythm in Atrial Fibrillation
1 other identifier
interventional
706
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 atrial-fibrillation
Started Apr 1998
Longer than P75 for phase_3 atrial-fibrillation
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1998
CompletedFirst Submitted
Initial submission to the registry
December 29, 2000
CompletedFirst Posted
Study publicly available on registry
January 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedJune 15, 2011
June 1, 2011
4.5 years
December 29, 2000
June 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment failure, defined as occurrence of atrial fibrillation or flutter after day 28 or failure to convert to sinus rhythm.
After day 28
Study Arms (2)
1
ACTIVE COMPARATORAmiodarone or Sotalol
2
ACTIVE COMPARATORSotalol
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients who have atrial fibrillation continuously for greater than 72 hours.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, 85723, United States
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, 72114-1706, United States
VA Central California Health Care System, Fresno
Fresno, California, 93703, United States
VA Medical Center, Loma Linda
Loma Linda, California, 92357, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290, United States
VA Greater Los Angeles HCS, Sepulveda
Sepulveda, California, 91343, United States
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073, United States
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516, United States
VA Medical Center, DC
Washington D.C., District of Columbia, 20422, United States
VA Medical Center, Bay Pines
Bay Pines, Florida, 33708, United States
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612, United States
VA Medical Center, Augusta
Augusta, Georgia, 30904, United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000, United States
VA Medical Center, Iowa City
Iowa City, Iowa, 52246-2208, United States
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, 02301, United States
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417, United States
VA Medical Center, Kansas City MO
Kansas City, Missouri, 64128, United States
VA Medical Center, St Louis
St Louis, Missouri, 63106, United States
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, 87108-5153, United States
VA Medical Center, Fargo
Fargo, North Dakota, 58102, United States
VA Medical Center, Portland
Portland, Oregon, 97201, United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240, United States
VA Medical Center, Providence
Providence, Rhode Island, 02908, United States
VA Medical Center, Memphis
Memphis, Tennessee, 38104, United States
VA Medical Center
Nashville, Tennessee, 37212-2637, United States
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, 53705, United States
Related Publications (1)
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. doi: 10.1016/s0002-9149(03)00671-4.
PMID: 12914883RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bramah N. Singh
VA Greater Los Angeles Healthcare System, West LA
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
Study Record Dates
First Submitted
December 29, 2000
First Posted
January 1, 2001
Study Start
April 1, 1998
Primary Completion
October 1, 2002
Study Completion
December 1, 2003
Last Updated
June 15, 2011
Record last verified: 2011-06