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

NCT ID: NCT01026090

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-12-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dronedarone 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

Group Type: EXPERIMENTAL

Dronedarone

Intervention Type: DRUG

Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner)

Placebo pre-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

Group Type: PLACEBO_COMPARATOR

Dronedarone

Intervention Type: DRUG

Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner)

Placebo (for dronedarone)

Intervention Type: DRUG

film-coated tablet strictly identical in appearance

Oral administration under fed conditions (during breakfast and dinner)

Interventions

Dronedarone

Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner)

Intervention Type: DRUG

Placebo (for dronedarone)

film-coated tablet strictly identical in appearance

Oral administration under fed conditions (during breakfast and dinner)

Intervention Type: DRUG

Other Intervention Names

MULTAQ; SR33589

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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 1240021

Greater Sudbury, , Canada

Investigational Site Number 1240039

Greater Sudbury, , Canada

Investigational Site Number 1240001

Greenfield Park, , Canada

Investigational Site Number 1240046

Grimsby, , Canada

Investigational Site Number 1240040

Hamilton, , Canada

Investigational Site Number 1240037

Hamilton, , Canada

Investigational Site Number 1240044

Kingston, , Canada

Investigational Site Number 1240029

Kitchener, , Canada

Investigational Site Number 1240013

Laval, , Canada

Investigational Site Number 1240043

Lévis, , Canada

Investigational Site Number 1240038

Maple Ridge, , Canada

Investigational Site Number 1240023

Montreal, , Canada

Investigational Site Number 1240006

Montreal, , Canada

Investigational Site Number 1240008

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 1240003

Saint-Charles-Borromée, , Canada

Investigational Site Number 1240053

Saskatoon, , Canada

Investigational Site Number 1240016

Scarborough, , Canada

Investigational Site Number 1240027

Sherbrooke, , Canada

Investigational Site Number 1240007

St. Georges, , Canada

Investigational Site Number 1240041

St. John's, , Canada

Investigational Site Number 1240002

Ste-Foy, , Canada

Investigational Site Number 1240025

Toronto, , Canada

Investigational Site Number 1240011

Toronto, , Canada

Investigational Site Number 1240019

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, , Canada

Countries

Canada

Other Identifiers

DRONE_L_04742

Identifier Type: -

Identifier Source: org_study_id