Clinical trial NCT00259428: EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)
Official title: EURopean Trial In Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: Atrial Fibrillation
Atrial Flutter
Arrhythmia
Anti-Arrhythmia agents
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-11-29
Enrollment: 615
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
Secondary outcomes:
measure: - AF/AFL related symptoms collected at the time of ECG/TTEM recording,
measure: - mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence (12-lead ECG or TTEM)
measure: - time from presumed study drug near steady state defined as D5 midnight to first documented AF/AFL recurrence as indicated by ECG/TTEM recording.
Other outcomes:
Locations:
city: Diegem
country: Belgium
facility: Sanofi-Aventis Administrative Office
city: Praha
country: Czech Republic
facility: Sanofi-Aventis Administrative Office
city: Horsholm
country: Denmark
facility: Sanofi-Aventis Administrative Office
city: Helsinki
country: Finland
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi- Aventis Administrative Office
city: Milano
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-Aventis Administrative Office
city: Warszawa
country: Poland
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Guildford
country: United Kingdom
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD Clinical study director (CSD)
role: STUDY_DIRECTOR
References:
citation: Singh BN, Connolly SJ, Crijns HJ, Roy D, Kowey PR, Capucci A, Radzik D, Aliot EM, Hohnloser SH; EURIDIS and ADONIS Investigators. Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med. 2007 Sep 6;357(10):987-99. doi: 10.1056/NEJMoa054686.
citation: Handelsman Y, Bunch TJ, Rodbard HW, Steinberg BA, Thind M, Bigot G, Konigsberg L, Wieloch M, Kowey PR. Impact of dronedarone on patients with atrial fibrillation and diabetes: A sub-analysis of the ATHENA and EURIDIS/ADONIS studies. J Diabetes Complications. 2022 Jul;36(7):108227. doi: 10.1016/j.jdiacomp.2022.108227. Epub 2022 Jun 8.