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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

NCT00007605 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 706

Last updated 2011-06-15

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

Sotalol

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

Sponsors & Collaborators

Principal Investigators

  • Bramah N. Singh · VA Greater Los Angeles Healthcare System, West LA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-04-30
Primary Completion
2002-10-31
Completion
2003-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00007605 on ClinicalTrials.gov