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

NCT01026090 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2014-08-06

No results posted yet for this study

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

Interventions

DRUG

Dronedarone

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

DRUG

Placebo (for dronedarone)

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01026090 on ClinicalTrials.gov