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

A Phase 4 study testing Dronedarone in people with Atrial Fibrillation, run by Sanofi at 43 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Dronedarone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 292 participants
Where: 43 sitesCanada
Study dates: Nov 2009to Dec 2011
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 12Show fewer

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Antiarrhythmic drugs (AADs) other than dronedarone should not be administered during the study and should be withdrawn for at least five plasma half-lives prior to the first study drug administration;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.

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

Canada43 sites

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

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions: Atrial Fibrillation
Being tested: Dronedarone, Placebo (for dronedarone)
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DronedaroneDrug
Also called MULTAQ, SR33589
Film-coated tablet
Oral administration under fed conditions (during breakfast and dinner)
Placebo (for dronedarone)Drug
film-coated tablet strictly identical in appearance
Oral administration under fed conditions (during breakfast and dinner)

Study groups in NCT01026090
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Dronedarone; Drug: Placebo (for dronedarone)

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence
Measured: 6 months from initial cardioversion

Secondary outcomes (10)

Number of Symptomatic AF Recurrences/Patient/6 Months (With or Without ECG Confirmation)
Measured: up to 6 months from initial cardioversion
Characteristics of Symptomatic AF Recurrence (Frequency, Duration of Episodes, Type, Number, and Severity of AF Symptoms)
Measured: 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)
Measured: up to 7 days following initial cardioversion
Proportion of Participants With Symptomatic AF Recurrences (With or Without ECG Confirmation)
Measured: up to 6 months from initial cardioversion
Number of Electrical Cardioversions Per Patient
Measured: up to 6 months from intial cardioversion
Number of Shocks Required During Initial Cardioversion
Measured: during the initial cardioversion
Cumulative Amount of Energy Delivered and Shock Failure
Measured: during the initial cardioversion
Proportion of Participants With Immediate Recurrence of AF (From 5 Seconds to 5 Minutes After Electrical Shock)
Measured: during the initial cardioversion
Number of CV Hospitalizations
Measured: up to 6 months from initial cardioversion
Quality of Life, as Measured by Atrial Fibrillation Severity Scale (AFSS) and Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaires
Measured: Baseline and 6 months after initial cardioversion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Dec 2011

First posted4 Dec 2009 (estimated)
Study startNov 2009
Primary completionDec 2011
Study completionDec 2011

Why it stopped: 'Sponsor decision following recruitment issues, not related to any safety concerns in the study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 292 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01026090
Sponsor's protocol ID: DRONE_L_04742
Status last verified: Aug 2014
First submitted: 2 Dec 2009
Last updated: 6 Aug 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01026090
Acronym / sponsor ID: DRONE_L_04742
Conditions: Atrial Fibrillation
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: 'Sponsor decision following recruitment issues, not related to any safety concerns in the study
Enrolment: 292 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 4 Dec 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objective:

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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Dronedarone pre-cardioversion	Experimental	Drug: DronedaroneDronedarone 400 mg twice a day for 5-7 days prior to cardioversion, then dronedarone 400 mg twice a day for 6 months after cardioversion
Placebo pre-cardioversion	Placebo comparator	Drug: Dronedarone, Drug: Placebo (for dronedarone)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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DronedaroneAlso: MULTAQ, SR33589Film-coated tablet Oral administration under fed conditions (during breakfast and dinner)	Drug	Dronedarone pre-cardioversion, Placebo pre-cardioversion
Placebo (for dronedarone)film-coated tablet strictly identical in appearance Oral administration under fed conditions (during breakfast and dinner)	Drug	Placebo pre-cardioversion

Primary outcome

Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence
Time frame: 6 months from initial cardioversion

10 secondary outcomes

Number of Symptomatic AF Recurrences/Patient/6 Months (With or Without ECG Confirmation)
Time frame: up to 6 months from initial cardioversion
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
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
Proportion of Participants With Symptomatic AF Recurrences (With or Without ECG Confirmation)
Time frame: up to 6 months from initial cardioversion
Number of Electrical Cardioversions Per Patient
Time frame: up to 6 months from intial cardioversion
Number of Shocks Required During Initial Cardioversion
Time frame: during the initial cardioversion
Cumulative Amount of Energy Delivered and Shock Failure
Time frame: during the initial cardioversion
Proportion of Participants With Immediate Recurrence of AF (From 5 Seconds to 5 Minutes After Electrical Shock)
Time frame: during the initial cardioversion
Number of CV Hospitalizations
Time frame: up to 6 months from initial cardioversion
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

Results and safety

The study was stopped early (reason given: 'Sponsor decision following recruitment issues, not related to any safety concerns in the study). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Sciences & Operations study director

Sanofi

43 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dronedarone in people with Atrial Fibrillation, run by Sanofi at 43 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 'Sponsor decision following recruitment issues, not related to any safety concerns in the study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence (time frame: 6 months from initial cardioversion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01026090.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.