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

Sponsor
Sanofi (Industry)
Overall Status
Terminated
CT.gov ID
NCT01026090
Collaborator
(none)
292
Enrollment
43
Locations
2
Arms
25
Duration (Months)
6.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
292 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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

Drug: Dronedarone
Film-coated tablet Oral administration under fed conditions (during breakfast and dinner)
Other Names:
  • MULTAQ
  • SR33589

    		•
    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

    Drug: Dronedarone
    Film-coated tablet Oral administration under fed conditions (during breakfast and dinner)
    Other Names:
  • MULTAQ
  • SR33589

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

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence [6 months from initial cardioversion]

    Secondary Outcome Measures

    1. Number of Symptomatic AF Recurrences/Patient/6 Months (With or Without ECG Confirmation) [up to 6 months from initial cardioversion]

    2. Characteristics of Symptomatic AF Recurrence (Frequency, Duration of Episodes, Type, Number, and Severity of AF Symptoms) [up to 6 months from initial cardioversion]

    3. 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]

    4. Proportion of Participants With Symptomatic AF Recurrences (With or Without ECG Confirmation) [up to 6 months from initial cardioversion]

    5. Number of Electrical Cardioversions Per Patient [up to 6 months from intial cardioversion]

    6. Number of Shocks Required During Initial Cardioversion [during the initial cardioversion]

    7. Cumulative Amount of Energy Delivered and Shock Failure [during the initial cardioversion]

    8. Proportion of Participants With Immediate Recurrence of AF (From 5 Seconds to 5 Minutes After Electrical Shock) [during the initial cardioversion]

    9. Number of CV Hospitalizations [up to 6 months from initial cardioversion]

    10. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number 1240033 Abbotsford Canada V2S3N5
    2 Investigational Site Number 1240026 Barrie Canada L4M4S5
    3 Investigational Site Number 1240050 Calgary Canada T2E7C5
    4 Investigational Site Number 1240010 Cambridge Canada N1R6V6
    5 Investigational Site Number 1240049 Edmonton Canada T5H4B9
    6 Investigational Site Number 1240005 Granby Canada J2G1T7
    7 Investigational Site Number 1240001 Greenfield Park Canada J4V2G8
    8 Investigational Site Number 1240046 Grimsby Canada L3M 1P3
    9 Investigational Site Number 1240040 Hamilton Canada L8L 2X2
    10 Investigational Site Number 1240037 Hamilton Canada L8N 3Z5
    11 Investigational Site Number 1240044 Kingston Canada K7L2V7
    12 Investigational Site Number 1240029 Kitchener Canada N2N2A8
    13 Investigational Site Number 1240013 Laval Canada H7S2M5
    14 Investigational Site Number 1240043 Levis Canada G6V3Z1
    15 Investigational Site Number 1240038 Maple Ridge Canada V2X5Z6
    16 Investigational Site Number 1240023 Montreal Canada H1T1C8
    17 Investigational Site Number 1240006 Montreal Canada H3G 1A4
    18 Investigational Site Number 1240008 Montreal Canada H4J1C5
    19 Investigational Site Number 1240018 Newmarket Canada L3Y8C3
    20 Investigational Site Number 1240012 Niagara Falls Canada L2E7H1
    21 Investigational Site Number 1240020 North York Canada M2J1W8
    22 Investigational Site Number 1240015 Oshawa Canada L1J2J9
    23 Investigational Site Number 1240036 Oshawa Canada
    24 Investigational Site Number 1240024 Ottawa Canada K1Y4W7
    25 Investigational Site Number 1240032 Ottawa Canada K2G3M8
    26 Investigational Site Number 1240056 Red Deer Canada T4N4E7
    27 Investigational Site Number 1240053 Saskatoon Canada S7N0W8
    28 Investigational Site Number 1240016 Scarborough Canada M1E5E9
    29 Investigational Site Number 1240027 Sherbrooke Canada J1H 5N4
    30 Investigational Site Number 1240003 St-Charles Borromee Canada J6E6J2
    31 Investigational Site Number 1240007 St-Georges Canada G5Y 4T8
    32 Investigational Site Number 1240041 St. John Canada E2L 4L2
    33 Investigational Site Number 1240002 Ste-Foy Canada G1V4G5
    34 Investigational Site Number 1240021 Sudbury Canada P3C5K7
    35 Investigational Site Number 1240039 Sudbury Canada P3E2N8
    36 Investigational Site Number 1240025 Toronto Canada M4N3M5
    37 Investigational Site Number 1240011 Toronto Canada M5C 2T2
    38 Investigational Site Number 1240019 Toronto Canada M5G2C4
    39 Investigational Site Number 1240009 Trois-Rivières Canada G8Z 4K4
    40 Investigational Site Number 1240047 Vancouver Canada V5Z1M6
    41 Investigational Site Number 1240035 Victoria Canada V8R4R2
    42 Investigational Site Number 1240014 Willowdale Canada M2K2W2
    43 Investigational Site Number 1240051 Windsor Canada N8X3N9

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT01026090
    Other Study ID Numbers:
    • DRONE_L_04742
    First Posted:
    Dec 4, 2009
    Last Update Posted:
    Aug 6, 2014
    Last Verified:
    Aug 1, 2014
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Dronedarone

    Study Results

    No Results Posted as of Aug 6, 2014