Clinical trial NCT01026090: Dronedarone Pattern of Use in Patients Scheduled for Elective Cardioversion (ELECTRA)
Official title: A Phase IV, Double-blind, Placebo-controlled, Canadian Multicentre Study Comparing Two Treatment Strategies of Dronedarone Administration Following ELECTive caRdioversion for Prevention of Symptomatic Atrial Fibrillation (AF) Recurrence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-12-04
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence
timeFrame: 6 months from initial cardioversion
Secondary outcomes:
measure: Number of Symptomatic AF Recurrences/Patient/6 Months (With or Without ECG Confirmation)
timeFrame: up to 6 months from initial cardioversion
measure: Characteristics of Symptomatic AF Recurrence (Frequency, Duration of Episodes, Type, Number, and Severity of AF Symptoms)
timeFrame: up to 6 months from initial cardioversion
measure: Proportion of Participants With Early Recurrence of AF (i.e. From 5 Minutes to to 7 Days Following Cardioversion)
timeFrame: up to 7 days following initial cardioversion
measure: Proportion of Participants With Symptomatic AF Recurrences (With or Without ECG Confirmation)
timeFrame: up to 6 months from initial cardioversion
measure: Number of Electrical Cardioversions Per Patient
timeFrame: up to 6 months from intial cardioversion
measure: Number of Shocks Required During Initial Cardioversion
timeFrame: during the initial cardioversion
measure: Cumulative Amount of Energy Delivered and Shock Failure
timeFrame: during the initial cardioversion
measure: Proportion of Participants With Immediate Recurrence of AF (From 5 Seconds to 5 Minutes After Electrical Shock)
timeFrame: during the initial cardioversion
measure: Number of CV Hospitalizations
timeFrame: up to 6 months from initial cardioversion
measure: Quality of Life, as Measured by Atrial Fibrillation Severity Scale (AFSS) and Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaires
timeFrame: Baseline and 6 months after initial cardioversion
Other outcomes:
Locations:
city: Abbotsford
country: Canada
facility: Investigational Site Number 1240033
city: Barrie
country: Canada
facility: Investigational Site Number 1240026
city: Calgary
country: Canada
facility: Investigational Site Number 1240050
city: Cambridge
country: Canada
facility: Investigational Site Number 1240010
city: Edmonton
country: Canada
facility: Investigational Site Number 1240049
city: Granby
country: Canada
facility: Investigational Site Number 1240005
city: Greenfield Park
country: Canada
facility: Investigational Site Number 1240001
city: Grimsby
country: Canada
facility: Investigational Site Number 1240046
city: Hamilton
country: Canada
facility: Investigational Site Number 1240040
city: Hamilton
country: Canada
facility: Investigational Site Number 1240037
city: Kingston
country: Canada
facility: Investigational Site Number 1240044
city: Kitchener
country: Canada
facility: Investigational Site Number 1240029
city: Laval
country: Canada
facility: Investigational Site Number 1240013
city: Levis
country: Canada
facility: Investigational Site Number 1240043
city: Maple Ridge
country: Canada
facility: Investigational Site Number 1240038
city: Montreal
country: Canada
facility: Investigational Site Number 1240023
city: Montreal
country: Canada
facility: Investigational Site Number 1240006
city: Montreal
country: Canada
facility: Investigational Site Number 1240008
city: Newmarket
country: Canada
facility: Investigational Site Number 1240018
city: Niagara Falls
country: Canada
facility: Investigational Site Number 1240012
city: North York
country: Canada
facility: Investigational Site Number 1240020
city: Oshawa
country: Canada
facility: Investigational Site Number 1240015
city: Oshawa
country: Canada
facility: Investigational Site Number 1240036
city: Ottawa
country: Canada
facility: Investigational Site Number 1240024
city: Ottawa
country: Canada
facility: Investigational Site Number 1240032
city: Red Deer
country: Canada
facility: Investigational Site Number 1240056
city: Saskatoon
country: Canada
facility: Investigational Site Number 1240053
city: Scarborough
country: Canada
facility: Investigational Site Number 1240016
city: Sherbrooke
country: Canada
facility: Investigational Site Number 1240027
city: St-Charles Borromee
country: Canada
facility: Investigational Site Number 1240003
city: St-Georges
country: Canada
facility: Investigational Site Number 1240007
city: St. John
country: Canada
facility: Investigational Site Number 1240041
city: Ste-Foy
country: Canada
facility: Investigational Site Number 1240002
city: Sudbury
country: Canada
facility: Investigational Site Number 1240021
city: Sudbury
country: Canada
facility: Investigational Site Number 1240039
city: Toronto
country: Canada
facility: Investigational Site Number 1240025
city: Toronto
country: Canada
facility: Investigational Site Number 1240011
city: Toronto
country: Canada
facility: Investigational Site Number 1240019
city: Trois-Rivières
country: Canada
facility: Investigational Site Number 1240009
city: Vancouver
country: Canada
facility: Investigational Site Number 1240047
city: Victoria
country: Canada
facility: Investigational Site Number 1240035
city: Willowdale
country: Canada
facility: Investigational Site Number 1240014
city: Windsor
country: Canada
facility: Investigational Site Number 1240051
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: