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

Atrial Fibrillation Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT01026090
• Study type: Interventional
• Source: Sanofi
• Status: Terminated
• Phase: Phase 4
• Start date: November 2009
• Completion date: December 2011