Dronedarone Pattern of Use in Patients Scheduled for Elective Cardioversion (ELECTRA)

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01026090
• Other study ID #: DRONE_L_04742
• Status: Terminated
• Phase: Phase 4
• First received: December 2, 2009
• Last updated: August 5, 2014
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 292
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Dronedarone
Film-coated tablet Oral administration under fed conditions (during breakfast and dinner)
• Placebo (for dronedarone)
film-coated tablet strictly identical in appearance Oral administration under fed conditions (during breakfast and dinner)

Locations

Country	Name	City	State
Canada	Investigational Site Number 1240033	Abbotsford
Canada	Investigational Site Number 1240026	Barrie
Canada	Investigational Site Number 1240050	Calgary
Canada	Investigational Site Number 1240010	Cambridge
Canada	Investigational Site Number 1240049	Edmonton
Canada	Investigational Site Number 1240005	Granby
Canada	Investigational Site Number 1240001	Greenfield Park
Canada	Investigational Site Number 1240046	Grimsby
Canada	Investigational Site Number 1240037	Hamilton
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 1240043	Levis
Canada	Investigational Site Number 1240038	Maple Ridge
Canada	Investigational Site Number 1240006	Montreal
Canada	Investigational Site Number 1240008	Montreal
Canada	Investigational Site Number 1240023	Montreal
Canada	Investigational Site Number 1240018	Newmarket
Canada	Investigational Site Number 1240012	Niagara Falls
Canada	Investigational Site Number 1240020	North York
Canada	Investigational Site Number 1240015	Oshawa
Canada	Investigational Site Number 1240036	Oshawa
Canada	Investigational Site Number 1240024	Ottawa
Canada	Investigational Site Number 1240032	Ottawa
Canada	Investigational Site Number 1240056	Red Deer
Canada	Investigational Site Number 1240053	Saskatoon
Canada	Investigational Site Number 1240016	Scarborough
Canada	Investigational Site Number 1240027	Sherbrooke
Canada	Investigational Site Number 1240003	St-Charles Borromee
Canada	Investigational Site Number 1240007	St-Georges
Canada	Investigational Site Number 1240041	St. John
Canada	Investigational Site Number 1240002	Ste-Foy
Canada	Investigational Site Number 1240021	Sudbury
Canada	Investigational Site Number 1240039	Sudbury
Canada	Investigational Site Number 1240011	Toronto
Canada	Investigational Site Number 1240019	Toronto
Canada	Investigational Site Number 1240025	Toronto
Canada	Investigational Site Number 1240009	Trois-Rivières
Canada	Investigational Site Number 1240047	Vancouver
Canada	Investigational Site Number 1240035	Victoria
Canada	Investigational Site Number 1240014	Willowdale
Canada	Investigational Site Number 1240051	Windsor

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence		6 months from initial cardioversion	No
Secondary	Number of Symptomatic AF Recurrences/Patient/6 Months (With or Without ECG Confirmation)		up to 6 months from initial cardioversion	No
Secondary	Characteristics of Symptomatic AF Recurrence (Frequency, Duration of Episodes, Type, Number, and Severity of AF Symptoms)		up to 6 months from initial cardioversion	No
Secondary	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	No
Secondary	Proportion of Participants With Symptomatic AF Recurrences (With or Without ECG Confirmation)		up to 6 months from initial cardioversion	No
Secondary	Number of Electrical Cardioversions Per Patient		up to 6 months from intial cardioversion	No
Secondary	Number of Shocks Required During Initial Cardioversion		during the initial cardioversion	No
Secondary	Cumulative Amount of Energy Delivered and Shock Failure		during the initial cardioversion	No
Secondary	Proportion of Participants With Immediate Recurrence of AF (From 5 Seconds to 5 Minutes After Electrical Shock)		during the initial cardioversion	No
Secondary	Number of CV Hospitalizations		up to 6 months from initial cardioversion	No
Secondary	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	No