Dronedarone Pattern of Use in Patients Scheduled for Elective Cardioversion (ELECTRA)
- Conditions
- Atrial Fibrillation
- Interventions
- Drug: Placebo (for dronedarone)
- Registration Number
- NCT01026090
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To determine whether daily administration of dronedarone started 5-7 days before cardioversion is superior to dronedarone started only after cardioversion with respect to the absence of symptomatic, ECG confirmed, atrial fibrillation (AF) recurrence over 6 months in adult patients with persistent AF, for whom cardioversion is clinically indicated and planned to reduce symptoms and antiarrhythmic treatment is clinically indicated to reduce the risk of cardiovascular hospitalization due to AF.
Secondary Objectives:
Main Secondary :
* To assess the number of symptomatic AF recurrences/patient/6 months with and without ECG confirmation;
* To assess characteristics of symptomatic AF recurrence in the two treatment arms (frequency, duration of episodes, type, number, and severity of AF symptoms per patient);
* To compare the rates of early recurrences of AF between the two treatment strategies;
Other secondary:
* To assess whether there is a difference in proportion of patients with symptomatic AF recurrences (with and without ECG confirmation) between the two treatment strategies;
* To assess whether there is a difference in number of electrical cardioversions per patient between the two treatment strategies;
* To assess the impact of the two strategies on number of shocks, cumulative amount of energy delivered, shock failure, and immediate success of cardioversion;
* To assess whether there is a difference in rate of cardiovascular (CV) hospitalizations and length of hospital stay between the two treatment strategies;
* To assess whether there is a difference in quality of life between the two treatment strategies.
- Detailed Description
The study period of approximatively 6 months consisted in:
* Double-blind treatment period (placebo or dronedarone) for 5-7 days prior to cardioversion;
* Electrical cardioversion;
* Open-label treatment period with dronedarone for 6 months after cardioversion.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 292
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dronedarone pre-cardioversion Dronedarone 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 pre-cardioversion Placebo (for dronedarone) 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 Placebo pre-cardioversion Dronedarone 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
- Primary Outcome Measures
Name Time Method Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence 6 months from initial cardioversion
- Secondary Outcome Measures
Name Time Method Cumulative Amount of Energy Delivered and Shock Failure during the initial cardioversion Number of Symptomatic AF Recurrences/Patient/6 Months (With or Without ECG Confirmation) up to 6 months from initial cardioversion Characteristics of Symptomatic AF Recurrence (Frequency, Duration of Episodes, Type, Number, and Severity of AF Symptoms) up to 6 months from initial cardioversion Proportion of Participants With Symptomatic AF Recurrences (With or Without ECG Confirmation) up to 6 months from initial cardioversion Number of Shocks Required During Initial Cardioversion during the initial cardioversion Number of Electrical Cardioversions Per Patient up to 6 months from intial cardioversion Proportion of Participants With Early Recurrence of AF (i.e. From 5 Minutes to to 7 Days Following Cardioversion) up to 7 days following initial cardioversion Proportion of Participants With Immediate Recurrence of AF (From 5 Seconds to 5 Minutes After Electrical Shock) during the initial cardioversion Number of CV Hospitalizations up to 6 months from initial cardioversion Quality of Life, as Measured by Atrial Fibrillation Severity Scale (AFSS) and Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaires Baseline and 6 months after initial cardioversion
Trial Locations
- Locations (43)
Investigational Site Number 1240002
🇨🇦Ste-Foy, Canada
Investigational Site Number 1240018
🇨🇦Newmarket, Canada
Investigational Site Number 1240012
🇨🇦Niagara Falls, Canada
Investigational Site Number 1240026
🇨🇦Barrie, Canada
Investigational Site Number 1240050
🇨🇦Calgary, Canada
Investigational Site Number 1240037
🇨🇦Hamilton, Canada
Investigational Site Number 1240023
🇨🇦Montreal, Canada
Investigational Site Number 1240020
🇨🇦North York, Canada
Investigational Site Number 1240039
🇨🇦Sudbury, Canada
Investigational Site Number 1240033
🇨🇦Abbotsford, Canada
Investigational Site Number 1240010
🇨🇦Cambridge, Canada
Investigational Site Number 1240016
🇨🇦Scarborough, Canada
Investigational Site Number 1240003
🇨🇦St-Charles Borromee, Canada
Investigational Site Number 1240043
🇨🇦Levis, Canada
Investigational Site Number 1240005
🇨🇦Granby, Canada
Investigational Site Number 1240032
🇨🇦Ottawa, Canada
Investigational Site Number 1240015
🇨🇦Oshawa, Canada
Investigational Site Number 1240053
🇨🇦Saskatoon, Canada
Investigational Site Number 1240027
🇨🇦Sherbrooke, Canada
Investigational Site Number 1240041
🇨🇦St. John, Canada
Investigational Site Number 1240009
🇨🇦Trois-Rivières, Canada
Investigational Site Number 1240051
🇨🇦Windsor, Canada
Investigational Site Number 1240001
🇨🇦Greenfield Park, Canada
Investigational Site Number 1240049
🇨🇦Edmonton, Canada
Investigational Site Number 1240046
🇨🇦Grimsby, Canada
Investigational Site Number 1240040
🇨🇦Hamilton, Canada
Investigational Site Number 1240044
🇨🇦Kingston, Canada
Investigational Site Number 1240029
🇨🇦Kitchener, Canada
Investigational Site Number 1240013
🇨🇦Laval, Canada
Investigational Site Number 1240038
🇨🇦Maple Ridge, Canada
Investigational Site Number 1240006
🇨🇦Montreal, Canada
Investigational Site Number 1240008
🇨🇦Montreal, Canada
Investigational Site Number 1240036
🇨🇦Oshawa, Canada
Investigational Site Number 1240024
🇨🇦Ottawa, Canada
Investigational Site Number 1240056
🇨🇦Red Deer, Canada
Investigational Site Number 1240007
🇨🇦St-Georges, Canada
Investigational Site Number 1240025
🇨🇦Toronto, Canada
Investigational Site Number 1240021
🇨🇦Sudbury, Canada
Investigational Site Number 1240011
🇨🇦Toronto, Canada
Investigational Site Number 1240019
🇨🇦Toronto, Canada
Investigational Site Number 1240047
🇨🇦Vancouver, Canada
Investigational Site Number 1240035
🇨🇦Victoria, Canada
Investigational Site Number 1240014
🇨🇦Willowdale, Canada