EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)

Phase 3

Completed

• Conditions: Atrial Fibrillation; Atrial Flutter
• Interventions: Drug: Dronedarone (SR33589); Drug: placebo

• Registration Number: NCT00259428
• Lead Sponsor: Sanofi

Brief Summary

To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL).

To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.

To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence.

Detailed Description

This is a double-blind, parallel arm, placebo-controlled, multicentre, multinational, phase III study.

To be eligible, patients must be in normal sinus rhythm at randomisation and must have an ECG-documented history of recent AF/AFL reverted to normal sinus rhythm by electrical, pharmacological or spontaneous conversion

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2005-11-25
• Study First Submitted QC: 2005-11-25
• Study First Posted: 2005-11-29
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-08
• Last Update Posted: 2010-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 615

Inclusion Criteria

• Patients of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at the time of randomization and with at least one ECG-documented AF/AFL episode in the last 3 months.

Exclusion Criteria

• MAIN CRITERIA (non-exhaustive list, see protocol for details):

Women of childbearing potential without adequate birth control, Pregnant women, Breastfeeding women, Congestive heart failure NYHA class III or IV, Conditions which increase the risk of severe antiarrhythmic drug side effects, Severe associated conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dronedarone 400mg bid	Dronedarone (SR33589)	dronedarone 400mg tablets
Placebo	placebo	matching placebo tablets

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence

Secondary Outcome Measures

Name	Time	Method
- AF/AFL related symptoms collected at the time of ECG/TTEM recording,
- mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence (12-lead ECG or TTEM)
- time from presumed study drug near steady state defined as D5 midnight to first documented AF/AFL recurrence as indicated by ECG/TTEM recording.

Trial Locations

Locations (2)

Sanofi- Aventis Administrative Office; 🇭🇺 Budapest, Hungary

Sanofi-Aventis Administrative Office; 🇬🇧 Guildford, United Kingdom