Dronedarone Pattern of Use in Patients Scheduled for Elective Cardioversion (ELECTRA) - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT01026090

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, 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 Objective:

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 (ERAF) 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 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 DRONEDARONE	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) 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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Shock

Drug Information available for: Dronedarone

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Proportion of patients with at least one symptomatic, ECG confirmed, AF recurrence within 6 months taking into account when the first event occurred. [ Time Frame: Month 3, Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of electrical cardioversions per patient [ Time Frame: Month 3, Month 6 ] [ Designated as safety issue: No ]
Number of shocks required [ Time Frame: during the first cardioversion ] [ Designated as safety issue: No ]
Presence of immediate recurrence of AF (IRAF: immediate recurrence of atrial fibrillation) after the initial cardioversion [ Time Frame: after 5 seconds and less than 5 minutes after electrical shock ] [ Designated as safety issue: No ]
Number of CV hospitalizations, taking into account when the hospitalization occurred, and duration of hospital stay [ Time Frame: Month 3, Month 6 ] [ Designated as safety issue: No ]
Quality of Life, as measured by AFSS questionnaire [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
Number of symptomatic AF recurrences/patient/6 months with and without ECG confirmation [ Time Frame: Month 3, Month 6 ] [ Designated as safety issue: No ]
Characteristics of symptomatic AF recurrence in the two treatment arms (frequency, duration of episodes, type, number, and severity of AF symptoms per patient) [ Time Frame: Month 3, Month 6 ] [ Designated as safety issue: No ]
Rates of early recurrences of AF (ERAF not IRAF) between the two treatment strategies [ Time Frame: 5 minutes to 7 days following cardioversion ] [ Designated as safety issue: No ]
Difference in proportion of patients with symptomatic AF recurrences (with and without ECG confirmation) between the two treatment strategies [ Time Frame: Month 3, Month 6 ] [ Designated as safety issue: No ]
Cumulative amount of energy delivered, shock failure [ Time Frame: during the first cardioversion ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
Experimental: A Dronedarone 400 mg BID for 5-7 days, followed by electrical cardioversion and continuation of dronedarone treatment for 6 months	Drug: DRONEDARONE Pharmaceutical form: Tablet Route of administration: Oral
Placebo Comparator: B Placebo BID for 5-7 days, followed by electrical cardioversion and followed by dronedarone 400 mg BID for 6 months	Drug: PLACEBO DRONEDARONE Pharmaceutical form: Tablet Route of administration: Oral

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 is clinically indicated and planned to reduce symptoms and antiarrhythmic treatment is 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 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 must not be administered during the study and must be withdrawn for at least five plasma half-lives prior to the first study drug administration
Dronedarone must not be co-administered with strong CYP3A4 inhibitors
Dronedarone must 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

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

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Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT01026090 History of Changes
Other Study ID Numbers:	DRONE_L_04742
Study First Received:	December 2, 2009
Last Updated:	March 7, 2012
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 May 23, 2012