Dronedarone Pattern of Use in Patients Scheduled for Elective Cardioversion (ELECTRA)
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01026090
First received: December 2, 2009
Last updated: January 23, 2013
Last verified: January 2013
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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, 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: Dronedarone Drug: Placebo (for dronedarone) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) 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:
familial atrial fibrillation
Drug Information available for:
Dronedarone
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence [ Time Frame: 6 months from initial cardioversion ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Symptomatic AF Recurrences/Patient/6 Months (With or Without ECG Confirmation) [ Time Frame: up to 6 months from initial cardioversion ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Proportion of Participants With Symptomatic AF Recurrences (With or Without ECG Confirmation) [ Time Frame: up to 6 months from initial cardioversion ] [ Designated as safety issue: No ]
- Number of Electrical Cardioversions Per Patient [ Time Frame: up to 6 months from intial cardioversion ] [ Designated as safety issue: No ]
- Number of Shocks Required During Initial Cardioversion [ Time Frame: during the initial cardioversion ] [ Designated as safety issue: No ]
- Cumulative Amount of Energy Delivered and Shock Failure [ Time Frame: during the initial cardioversion ] [ Designated as safety issue: No ]
- Proportion of Participants With Immediate Recurrence of AF (From 5 Seconds to 5 Minutes After Electrical Shock) [ Time Frame: during the initial cardioversion ] [ Designated as safety issue: No ]
- Number of CV Hospitalizations [ Time Frame: up to 6 months from initial cardioversion ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 292 |
| Study Start Date: | November 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dronedarone pre-cardioversion
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
Film-coated tablet Oral administration under fed conditions (during breakfast and dinner) Other Names:
|
|
Placebo Comparator: Placebo pre-cardioversion
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
Film-coated tablet Oral administration under fed conditions (during breakfast and dinner) Other Names:
Drug: Placebo (for dronedarone)
film-coated tablet strictly identical in appearance Oral administration under fed conditions (during breakfast and dinner) |
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.
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 was clinically indicated and planned to reduce symptoms and antiarrhythmic treatment was 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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026090
Locations
| Canada | |
| Investigational Site Number 1240033 | |
| Abbotsford, Canada, V2S3N5 | |
| Investigational Site Number 1240026 | |
| Barrie, Canada, L4M4S5 | |
| Investigational Site Number 1240050 | |
| Calgary, Canada, T2E7C5 | |
| Investigational Site Number 1240010 | |
| Cambridge, Canada, N1R6V6 | |
| Investigational Site Number 1240049 | |
| Edmonton, Canada, T5H4B9 | |
| Investigational Site Number 1240005 | |
| Granby, Canada, J2G1T7 | |
| Investigational Site Number 1240001 | |
| Greenfield Park, Canada, J4V2G8 | |
| Investigational Site Number 1240046 | |
| Grimsby, Canada, L3M 1P3 | |
| Investigational Site Number 1240040 | |
| Hamilton, Canada, L8L 2X2 | |
| Investigational Site Number 1240037 | |
| Hamilton, Canada, L8N 3Z5 | |
| Investigational Site Number 1240044 | |
| Kingston, Canada, K7L2V7 | |
| Investigational Site Number 1240029 | |
| Kitchener, Canada, N2N2A8 | |
| Investigational Site Number 1240013 | |
| Laval, Canada, H7S2M5 | |
| Investigational Site Number 1240043 | |
| Levis, Canada, G6V3Z1 | |
| Investigational Site Number 1240038 | |
| Maple Ridge, Canada, V2X5Z6 | |
| Investigational Site Number 1240008 | |
| Montreal, Canada, H4J1C5 | |
| Investigational Site Number 1240023 | |
| Montreal, Canada, H1T1C8 | |
| Investigational Site Number 1240006 | |
| Montreal, Canada, H3G 1A4 | |
| Investigational Site Number 1240018 | |
| Newmarket, Canada, L3Y8C3 | |
| Investigational Site Number 1240012 | |
| Niagara Falls, Canada, L2E7H1 | |
| Investigational Site Number 1240020 | |
| North York, Canada, M2J1W8 | |
| Investigational Site Number 1240015 | |
| Oshawa, Canada, L1J2J9 | |
| Investigational Site Number 1240036 | |
| Oshawa, Canada | |
| Investigational Site Number 1240032 | |
| Ottawa, Canada, K2G3M8 | |
| Investigational Site Number 1240024 | |
| Ottawa, Canada, K1Y4W7 | |
| Investigational Site Number 1240056 | |
| Red Deer, Canada, T4N4E7 | |
| Investigational Site Number 1240053 | |
| Saskatoon, Canada, S7N0W8 | |
| Investigational Site Number 1240016 | |
| Scarborough, Canada, M1E5E9 | |
| Investigational Site Number 1240027 | |
| Sherbrooke, Canada, J1H 5N4 | |
| Investigational Site Number 1240003 | |
| St-Charles Borromee, Canada, J6E6J2 | |
| Investigational Site Number 1240007 | |
| St-Georges, Canada, G5Y 4T8 | |
| Investigational Site Number 1240041 | |
| St. John, Canada, E2L 4L2 | |
| Investigational Site Number 1240002 | |
| Ste-Foy, Canada, G1V4G5 | |
| Investigational Site Number 1240039 | |
| Sudbury, Canada, P3E2N8 | |
| Investigational Site Number 1240021 | |
| Sudbury, Canada, P3C5K7 | |
| Investigational Site Number 1240019 | |
| Toronto, Canada, M5G2C4 | |
| Investigational Site Number 1240011 | |
| Toronto, Canada, M5C 2T2 | |
| Investigational Site Number 1240025 | |
| Toronto, Canada, M4N3M5 | |
| Investigational Site Number 1240009 | |
| Trois-Rivières, Canada, G8Z 4K4 | |
| Investigational Site Number 1240047 | |
| Vancouver, Canada, V5Z1M6 | |
| Investigational Site Number 1240035 | |
| Victoria, Canada, V8R4R2 | |
| Investigational Site Number 1240014 | |
| Willowdale, Canada, M2K2W2 | |
| Investigational Site Number 1240051 | |
| Windsor, Canada, N8X3N9 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01026090 History of Changes |
| Other Study ID Numbers: | DRONE_L_04742 |
| Study First Received: | December 2, 2009 |
| Last Updated: | January 23, 2013 |
| 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 June 18, 2013