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

This study has been terminated.
('Sponsor decision following recruitment issues, not related to any safety concerns in the study)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01026090
First received: December 2, 2009
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Atrial Fibrillation
Drug: Dronedarone
Drug: Placebo (for dronedarone)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence [ Time Frame: 6 months from initial cardioversion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Symptomatic AF Recurrences/Patient/6 Months (With or Without ECG Confirmation) [ Time Frame: up to 6 months from initial cardioversion ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of Participants With Symptomatic AF Recurrences (With or Without ECG Confirmation) [ Time Frame: up to 6 months from initial cardioversion ] [ Designated as safety issue: No ]
  • Number of Electrical Cardioversions Per Patient [ Time Frame: up to 6 months from intial cardioversion ] [ Designated as safety issue: No ]
  • Number of Shocks Required During Initial Cardioversion [ Time Frame: during the initial cardioversion ] [ Designated as safety issue: No ]
  • Cumulative Amount of Energy Delivered and Shock Failure [ Time Frame: during the initial cardioversion ] [ Designated as safety issue: No ]
  • Proportion of Participants With Immediate Recurrence of AF (From 5 Seconds to 5 Minutes After Electrical Shock) [ Time Frame: during the initial cardioversion ] [ Designated as safety issue: No ]
  • Number of CV Hospitalizations [ Time Frame: up to 6 months from initial cardioversion ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 292
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026090

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01026090     History of Changes
Other Study ID Numbers: DRONE_L_04742
Study First Received: December 2, 2009
Last Updated: August 5, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on October 19, 2014