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

NCT01026090 | Terminated Phase 4 DMC

• 1 other identifier: DRONE_L_04742
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 43

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

  6 months from initial cardioversion

Secondary Outcomes (10)

• Number of Symptomatic AF Recurrences/Patient/6 Months (With or Without ECG Confirmation)

  up to 6 months from initial cardioversion

• Characteristics of Symptomatic AF Recurrence (Frequency, Duration of Episodes, Type, Number, and Severity of AF Symptoms)

  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)

  up to 7 days following initial cardioversion

• Proportion of Participants With Symptomatic AF Recurrences (With or Without ECG Confirmation)

  up to 6 months from initial cardioversion

• Number of Electrical Cardioversions Per Patient

  up to 6 months from intial cardioversion

Study Arms (2)

Dronedarone pre-cardioversion

EXPERIMENTAL

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

Placebo pre-cardioversion

PLACEBO COMPARATOR

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; Drug: Placebo (for dronedarone)

Interventions

Dronedarone DRUG

Film-coated tablet Oral administration under fed conditions (during breakfast and dinner)

Also known as: MULTAQ, SR33589

Dronedarone pre-cardioversion; Placebo pre-cardioversion

Placebo (for dronedarone) DRUG

film-coated tablet strictly identical in appearance Oral administration under fed conditions (during breakfast and dinner)

Placebo pre-cardioversion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (43)

Investigational Site Number 1240033

Abbotsford, V2S3N5, Canada

Location

Investigational Site Number 1240026

Barrie, L4M4S5, Canada

Location

Investigational Site Number 1240050

Calgary, T2E7C5, Canada

Location

Investigational Site Number 1240010

Cambridge, N1R6V6, Canada

Location

Investigational Site Number 1240049

Edmonton, T5H4B9, Canada

Location

Investigational Site Number 1240005

Granby, J2G1T7, Canada

Location

Investigational Site Number 1240021

Greater Sudbury, P3C5K7, Canada

Location

Investigational Site Number 1240039

Greater Sudbury, P3E2N8, Canada

Location

Investigational Site Number 1240001

Greenfield Park, J4V2G8, Canada

Location

Investigational Site Number 1240046

Grimsby, L3M 1P3, Canada

Location

Investigational Site Number 1240040

Hamilton, L8L 2X2, Canada

Location

Investigational Site Number 1240037

Hamilton, L8N 3Z5, Canada

Location

Investigational Site Number 1240044

Kingston, K7L2V7, Canada

Location

Investigational Site Number 1240029

Kitchener, N2N2A8, Canada

Location

Investigational Site Number 1240013

Laval, H7S2M5, Canada

Location

Investigational Site Number 1240043

Lévis, G6V3Z1, Canada

Location

Investigational Site Number 1240038

Maple Ridge, V2X5Z6, Canada

Location

Investigational Site Number 1240023

Montreal, H1T1C8, Canada

Location

Investigational Site Number 1240006

Montreal, H3G 1A4, Canada

Location

Investigational Site Number 1240008

Montreal, H4J1C5, Canada

Location

Investigational Site Number 1240018

Newmarket, L3Y8C3, Canada

Location

Investigational Site Number 1240012

Niagara Falls, L2E7H1, Canada

Location

Investigational Site Number 1240020

North York, M2J1W8, Canada

Location

Investigational Site Number 1240015

Oshawa, L1J2J9, Canada

Location

Investigational Site Number 1240036

Oshawa, Canada

Location

Investigational Site Number 1240024

Ottawa, K1Y4W7, Canada

Location

Investigational Site Number 1240032

Ottawa, K2G3M8, Canada

Location

Investigational Site Number 1240056

Red Deer, T4N4E7, Canada

Location

Investigational Site Number 1240003

Saint-Charles-Borromée, J6E6J2, Canada

Location

Investigational Site Number 1240053

Saskatoon, S7N0W8, Canada

Location

Investigational Site Number 1240016

Scarborough, M1E5E9, Canada

Location

Investigational Site Number 1240027

Sherbrooke, J1H 5N4, Canada

Location

Investigational Site Number 1240007

St. Georges, G5Y 4T8, Canada

Location

Investigational Site Number 1240041

St. John's, E2L 4L2, Canada

Location

Investigational Site Number 1240002

Ste-Foy, G1V4G5, Canada

Location

Investigational Site Number 1240025

Toronto, M4N3M5, Canada

Location

Investigational Site Number 1240011

Toronto, M5C 2T2, Canada

Location

Investigational Site Number 1240019

Toronto, M5G2C4, Canada

Location

Investigational Site Number 1240009

Trois-Rivières, G8Z 4K4, Canada

Location

Investigational Site Number 1240047

Vancouver, V5Z1M6, Canada

Location

Investigational Site Number 1240035

Victoria, V8R4R2, Canada

Location

Investigational Site Number 1240014

Willowdale, M2K2W2, Canada

Location

Investigational Site Number 1240051

Windsor, N8X3N9, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dronedarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amiodarone; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 4, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 6, 2014

Record last verified: 2014-08

Locations

CA (43)