Atrial Fibrillation, Atrial Flutter
Conditions
Keywords
Atrial Fibrillation, Atrial Flutter, Arrhythmia, Anti-Arrhythmia agents
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
Interventions
oral administration
DRUGplacebo
oral administration
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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. | — |
Countries
Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed