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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Dronedarone
Placebo (for dronedarone)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Antiarrhythmic drugs (AADs) other than dronedarone should not be administered during the study and should be withdrawn for at least five plasma half-lives prior to the first study drug administration;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.

Sites / Locations

  • Investigational Site Number 1240033
  • Investigational Site Number 1240026
  • Investigational Site Number 1240050
  • Investigational Site Number 1240010
  • Investigational Site Number 1240049
  • Investigational Site Number 1240005
  • Investigational Site Number 1240001
  • Investigational Site Number 1240046
  • Investigational Site Number 1240040
  • Investigational Site Number 1240037
  • Investigational Site Number 1240044
  • Investigational Site Number 1240029
  • Investigational Site Number 1240013
  • Investigational Site Number 1240043
  • Investigational Site Number 1240038
  • Investigational Site Number 1240023
  • Investigational Site Number 1240006
  • Investigational Site Number 1240008
  • Investigational Site Number 1240018
  • Investigational Site Number 1240012
  • Investigational Site Number 1240020
  • Investigational Site Number 1240015
  • Investigational Site Number 1240036
  • Investigational Site Number 1240024
  • Investigational Site Number 1240032
  • Investigational Site Number 1240056
  • Investigational Site Number 1240053
  • Investigational Site Number 1240016
  • Investigational Site Number 1240027
  • Investigational Site Number 1240003
  • Investigational Site Number 1240007
  • Investigational Site Number 1240041
  • Investigational Site Number 1240002
  • Investigational Site Number 1240021
  • Investigational Site Number 1240039
  • Investigational Site Number 1240025
  • Investigational Site Number 1240011
  • Investigational Site Number 1240019
  • Investigational Site Number 1240009
  • Investigational Site Number 1240047
  • Investigational Site Number 1240035
  • Investigational Site Number 1240014
  • Investigational Site Number 1240051

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dronedarone pre-cardioversion

Placebo pre-cardioversion

Arm Description

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 (for dronedarone) twice a day for 5-7 days prior to cardioversion, then dronedarone 400 mg twice a day for 6 months after cardioversion

Outcomes

Primary Outcome Measures

Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence

Secondary Outcome Measures

Number of Symptomatic AF Recurrences/Patient/6 Months (With or Without ECG Confirmation)
Characteristics of Symptomatic AF Recurrence (Frequency, Duration of Episodes, Type, Number, and Severity of AF Symptoms)
Proportion of Participants With Early Recurrence of AF (i.e. From 5 Minutes to to 7 Days Following Cardioversion)
Proportion of Participants With Symptomatic AF Recurrences (With or Without ECG Confirmation)
Number of Electrical Cardioversions Per Patient
Number of Shocks Required During Initial Cardioversion
Cumulative Amount of Energy Delivered and Shock Failure
Proportion of Participants With Immediate Recurrence of AF (From 5 Seconds to 5 Minutes After Electrical Shock)
Number of CV Hospitalizations
Quality of Life, as Measured by Atrial Fibrillation Severity Scale (AFSS) and Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaires

Full Information

First Posted
December 2, 2009
Last Updated
August 5, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01026090
Brief Title
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
'Sponsor decision following recruitment issues, not related to any safety concerns in the study
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dronedarone pre-cardioversion
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo pre-cardioversion
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dronedarone
Other Intervention Name(s)
MULTAQ, SR33589
Intervention Description
Film-coated tablet Oral administration under fed conditions (during breakfast and dinner)
Intervention Type
Drug
Intervention Name(s)
Placebo (for dronedarone)
Intervention Description
film-coated tablet strictly identical in appearance Oral administration under fed conditions (during breakfast and dinner)
Primary Outcome Measure Information:
Title
Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence
Time Frame
6 months from initial cardioversion
Secondary Outcome Measure Information:
Title
Number of Symptomatic AF Recurrences/Patient/6 Months (With or Without ECG Confirmation)
Time Frame
up to 6 months from initial cardioversion
Title
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
Title
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
Title
Proportion of Participants With Symptomatic AF Recurrences (With or Without ECG Confirmation)
Time Frame
up to 6 months from initial cardioversion
Title
Number of Electrical Cardioversions Per Patient
Time Frame
up to 6 months from intial cardioversion
Title
Number of Shocks Required During Initial Cardioversion
Time Frame
during the initial cardioversion
Title
Cumulative Amount of Energy Delivered and Shock Failure
Time Frame
during the initial cardioversion
Title
Proportion of Participants With Immediate Recurrence of AF (From 5 Seconds to 5 Minutes After Electrical Shock)
Time Frame
during the initial cardioversion
Title
Number of CV Hospitalizations
Time Frame
up to 6 months from initial cardioversion
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 1240033
City
Abbotsford
ZIP/Postal Code
V2S3N5
Country
Canada
Facility Name
Investigational Site Number 1240026
City
Barrie
ZIP/Postal Code
L4M4S5
Country
Canada
Facility Name
Investigational Site Number 1240050
City
Calgary
ZIP/Postal Code
T2E7C5
Country
Canada
Facility Name
Investigational Site Number 1240010
City
Cambridge
ZIP/Postal Code
N1R6V6
Country
Canada
Facility Name
Investigational Site Number 1240049
City
Edmonton
ZIP/Postal Code
T5H4B9
Country
Canada
Facility Name
Investigational Site Number 1240005
City
Granby
ZIP/Postal Code
J2G1T7
Country
Canada
Facility Name
Investigational Site Number 1240001
City
Greenfield Park
ZIP/Postal Code
J4V2G8
Country
Canada
Facility Name
Investigational Site Number 1240046
City
Grimsby
ZIP/Postal Code
L3M 1P3
Country
Canada
Facility Name
Investigational Site Number 1240040
City
Hamilton
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Investigational Site Number 1240037
City
Hamilton
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Investigational Site Number 1240044
City
Kingston
ZIP/Postal Code
K7L2V7
Country
Canada
Facility Name
Investigational Site Number 1240029
City
Kitchener
ZIP/Postal Code
N2N2A8
Country
Canada
Facility Name
Investigational Site Number 1240013
City
Laval
ZIP/Postal Code
H7S2M5
Country
Canada
Facility Name
Investigational Site Number 1240043
City
Levis
ZIP/Postal Code
G6V3Z1
Country
Canada
Facility Name
Investigational Site Number 1240038
City
Maple Ridge
ZIP/Postal Code
V2X5Z6
Country
Canada
Facility Name
Investigational Site Number 1240023
City
Montreal
ZIP/Postal Code
H1T1C8
Country
Canada
Facility Name
Investigational Site Number 1240006
City
Montreal
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Investigational Site Number 1240008
City
Montreal
ZIP/Postal Code
H4J1C5
Country
Canada
Facility Name
Investigational Site Number 1240018
City
Newmarket
ZIP/Postal Code
L3Y8C3
Country
Canada
Facility Name
Investigational Site Number 1240012
City
Niagara Falls
ZIP/Postal Code
L2E7H1
Country
Canada
Facility Name
Investigational Site Number 1240020
City
North York
ZIP/Postal Code
M2J1W8
Country
Canada
Facility Name
Investigational Site Number 1240015
City
Oshawa
ZIP/Postal Code
L1J2J9
Country
Canada
Facility Name
Investigational Site Number 1240036
City
Oshawa
Country
Canada
Facility Name
Investigational Site Number 1240024
City
Ottawa
ZIP/Postal Code
K1Y4W7
Country
Canada
Facility Name
Investigational Site Number 1240032
City
Ottawa
ZIP/Postal Code
K2G3M8
Country
Canada
Facility Name
Investigational Site Number 1240056
City
Red Deer
ZIP/Postal Code
T4N4E7
Country
Canada
Facility Name
Investigational Site Number 1240053
City
Saskatoon
ZIP/Postal Code
S7N0W8
Country
Canada
Facility Name
Investigational Site Number 1240016
City
Scarborough
ZIP/Postal Code
M1E5E9
Country
Canada
Facility Name
Investigational Site Number 1240027
City
Sherbrooke
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Investigational Site Number 1240003
City
St-Charles Borromee
ZIP/Postal Code
J6E6J2
Country
Canada
Facility Name
Investigational Site Number 1240007
City
St-Georges
ZIP/Postal Code
G5Y 4T8
Country
Canada
Facility Name
Investigational Site Number 1240041
City
St. John
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Investigational Site Number 1240002
City
Ste-Foy
ZIP/Postal Code
G1V4G5
Country
Canada
Facility Name
Investigational Site Number 1240021
City
Sudbury
ZIP/Postal Code
P3C5K7
Country
Canada
Facility Name
Investigational Site Number 1240039
City
Sudbury
ZIP/Postal Code
P3E2N8
Country
Canada
Facility Name
Investigational Site Number 1240025
City
Toronto
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
Investigational Site Number 1240011
City
Toronto
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Investigational Site Number 1240019
City
Toronto
ZIP/Postal Code
M5G2C4
Country
Canada
Facility Name
Investigational Site Number 1240009
City
Trois-Rivières
ZIP/Postal Code
G8Z 4K4
Country
Canada
Facility Name
Investigational Site Number 1240047
City
Vancouver
ZIP/Postal Code
V5Z1M6
Country
Canada
Facility Name
Investigational Site Number 1240035
City
Victoria
ZIP/Postal Code
V8R4R2
Country
Canada
Facility Name
Investigational Site Number 1240014
City
Willowdale
ZIP/Postal Code
M2K2W2
Country
Canada
Facility Name
Investigational Site Number 1240051
City
Windsor
ZIP/Postal Code
N8X3N9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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