Dronedarone Pattern of Use in Patients Scheduled for Elective Cardioversion (ELECTRA)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion criteria:
- Adult patients with persistent AF (current episode at the screening visit >72 hrs and <12 month duration), for whom cardioversion was clinically indicated and planned to reduce symptoms and antiarrhythmic treatment was clinically indicated to reduce the risk of cardiovascular hospitalization due to AF.
Exclusion criteria:
- Severe congestive heart failure (NYHA Class IV) and other unstable hemodynamic conditions;
- Bradycardia <50 bpm;
- QTc Bazett interval ≥500 ms;
- Second- or third- degree atrio-ventricular (AV) block, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker);
- Severe hepatic impairment;
- Pregnancy and lactation;
- History of hypersensitivity reactions to dronedarone or any of its excipients or component of the container.
Concomitant drugs:
- Antiarrhythmic drugs (AADs) other than dronedarone should not be administered during the study and should be withdrawn for at least five plasma half-lives prior to the first study drug administration;
- Dronedarone should not be co-administered with strong CYP3A4 inhibitors;
- Dronedarone should not be co-administered with drugs inducing torsades de pointes.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 1240033
- Investigational Site Number 1240026
- Investigational Site Number 1240050
- Investigational Site Number 1240010
- Investigational Site Number 1240049
- Investigational Site Number 1240005
- Investigational Site Number 1240001
- Investigational Site Number 1240046
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- Investigational Site Number 1240029
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- Investigational Site Number 1240043
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- Investigational Site Number 1240023
- Investigational Site Number 1240006
- Investigational Site Number 1240008
- Investigational Site Number 1240018
- Investigational Site Number 1240012
- Investigational Site Number 1240020
- Investigational Site Number 1240015
- Investigational Site Number 1240036
- Investigational Site Number 1240024
- Investigational Site Number 1240032
- Investigational Site Number 1240056
- Investigational Site Number 1240053
- Investigational Site Number 1240016
- Investigational Site Number 1240027
- Investigational Site Number 1240003
- Investigational Site Number 1240007
- Investigational Site Number 1240041
- Investigational Site Number 1240002
- Investigational Site Number 1240021
- Investigational Site Number 1240039
- Investigational Site Number 1240025
- Investigational Site Number 1240011
- Investigational Site Number 1240019
- Investigational Site Number 1240009
- Investigational Site Number 1240047
- Investigational Site Number 1240035
- Investigational Site Number 1240014
- Investigational Site Number 1240051
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Dronedarone pre-cardioversion
Placebo pre-cardioversion
Dronedarone 400 mg twice a day for 5-7 days prior to cardioversion, then dronedarone 400 mg twice a day for 6 months after cardioversion
Placebo (for dronedarone) twice a day for 5-7 days prior to cardioversion, then dronedarone 400 mg twice a day for 6 months after cardioversion