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

August 5, 2014 updated by: Sanofi

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

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

292

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Abbotsford, Canada, V2S3N5
        • Investigational Site Number 1240033
      • Barrie, Canada, L4M4S5
        • Investigational Site Number 1240026
      • Calgary, Canada, T2E7C5
        • Investigational Site Number 1240050
      • Cambridge, Canada, N1R6V6
        • Investigational Site Number 1240010
      • Edmonton, Canada, T5H4B9
        • Investigational Site Number 1240049
      • Granby, Canada, J2G1T7
        • Investigational Site Number 1240005
      • Greenfield Park, Canada, J4V2G8
        • Investigational Site Number 1240001
      • Grimsby, Canada, L3M 1P3
        • Investigational Site Number 1240046
      • Hamilton, Canada, L8L 2X2
        • Investigational Site Number 1240040
      • Hamilton, Canada, L8N 3Z5
        • Investigational Site Number 1240037
      • Kingston, Canada, K7L2V7
        • Investigational Site Number 1240044
      • Kitchener, Canada, N2N2A8
        • Investigational Site Number 1240029
      • Laval, Canada, H7S2M5
        • Investigational Site Number 1240013
      • Levis, Canada, G6V3Z1
        • Investigational Site Number 1240043
      • Maple Ridge, Canada, V2X5Z6
        • Investigational Site Number 1240038
      • Montreal, Canada, H1T1C8
        • Investigational Site Number 1240023
      • Montreal, Canada, H3G 1A4
        • Investigational Site Number 1240006
      • Montreal, Canada, H4J1C5
        • Investigational Site Number 1240008
      • Newmarket, Canada, L3Y8C3
        • Investigational Site Number 1240018
      • Niagara Falls, Canada, L2E7H1
        • Investigational Site Number 1240012
      • North York, Canada, M2J1W8
        • Investigational Site Number 1240020
      • Oshawa, Canada, L1J2J9
        • Investigational Site Number 1240015
      • Oshawa, Canada
        • Investigational Site Number 1240036
      • Ottawa, Canada, K1Y4W7
        • Investigational Site Number 1240024
      • Ottawa, Canada, K2G3M8
        • Investigational Site Number 1240032
      • Red Deer, Canada, T4N4E7
        • Investigational Site Number 1240056
      • Saskatoon, Canada, S7N0W8
        • Investigational Site Number 1240053
      • Scarborough, Canada, M1E5E9
        • Investigational Site Number 1240016
      • Sherbrooke, Canada, J1H 5N4
        • Investigational Site Number 1240027
      • St-Charles Borromee, Canada, J6E6J2
        • Investigational Site Number 1240003
      • St-Georges, Canada, G5Y 4T8
        • Investigational Site Number 1240007
      • St. John, Canada, E2L 4L2
        • Investigational Site Number 1240041
      • Ste-Foy, Canada, G1V4G5
        • Investigational Site Number 1240002
      • Sudbury, Canada, P3C5K7
        • Investigational Site Number 1240021
      • Sudbury, Canada, P3E2N8
        • Investigational Site Number 1240039
      • Toronto, Canada, M4N3M5
        • Investigational Site Number 1240025
      • Toronto, Canada, M5C 2T2
        • Investigational Site Number 1240011
      • Toronto, Canada, M5G2C4
        • Investigational Site Number 1240019
      • Trois-Rivières, Canada, G8Z 4K4
        • Investigational Site Number 1240009
      • Vancouver, Canada, V5Z1M6
        • Investigational Site Number 1240047
      • Victoria, Canada, V8R4R2
        • Investigational Site Number 1240035
      • Willowdale, Canada, M2K2W2
        • Investigational Site Number 1240014
      • Windsor, Canada, N8X3N9
        • Investigational Site Number 1240051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner)

Other Names:
  • SR33589
  • MULTAQ
Placebo Comparator: 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

Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner)

Other Names:
  • SR33589
  • MULTAQ

film-coated tablet strictly identical in appearance

Oral administration under fed conditions (during breakfast and dinner)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence
Time Frame: 6 months from initial cardioversion
6 months from initial cardioversion

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Symptomatic AF Recurrences/Patient/6 Months (With or Without ECG Confirmation)
Time Frame: up to 6 months from initial cardioversion
up to 6 months from initial cardioversion
Characteristics of Symptomatic AF Recurrence (Frequency, Duration of Episodes, Type, Number, and Severity of AF Symptoms)
Time Frame: up to 6 months from initial cardioversion
up to 6 months from initial cardioversion
Proportion of Participants With Early Recurrence of AF (i.e. From 5 Minutes to to 7 Days Following Cardioversion)
Time Frame: up to 7 days following initial cardioversion
up to 7 days following initial cardioversion
Proportion of Participants With Symptomatic AF Recurrences (With or Without ECG Confirmation)
Time Frame: up to 6 months from initial cardioversion
up to 6 months from initial cardioversion
Number of Electrical Cardioversions Per Patient
Time Frame: up to 6 months from intial cardioversion
up to 6 months from intial cardioversion
Number of Shocks Required During Initial Cardioversion
Time Frame: during the initial cardioversion
during the initial cardioversion
Cumulative Amount of Energy Delivered and Shock Failure
Time Frame: during the initial cardioversion
during the initial cardioversion
Proportion of Participants With Immediate Recurrence of AF (From 5 Seconds to 5 Minutes After Electrical Shock)
Time Frame: during the initial cardioversion
during the initial cardioversion
Number of CV Hospitalizations
Time Frame: up to 6 months from initial cardioversion
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
Time Frame: Baseline and 6 months after initial cardioversion
Baseline and 6 months after initial cardioversion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 3, 2009

First Posted (Estimate)

December 4, 2009

Study Record Updates

Last Update Posted (Estimate)

August 6, 2014

Last Update Submitted That Met QC Criteria

August 5, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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