Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174785
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2005-09-13
Brief Title:
A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Placebo-controlledDouble-blindParallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial FibrillationAtrial Flutter AFAFL
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATHENA
Brief Summary:
To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillationatrial flutter AFAFL
To assess that dronedarone is well tolerated in this population
To assess that dronedarone is well tolerated in this population
Detailed Description:
This is a prospective multinational double-blind randomized multi-center placebo-controlled parallel-group trial evaluating the effects of dronedarone versus placebo ratio 11 over a minimum treatment duration of 12 months and a mean follow-up duration of 175 years in AFAFL patients Patients can be included in the study while in atrial fibrillationflutter or in sinus rhythm if conversion has occurred either spontaneously or following a procedure such as electrical cardioversion or overdrive pacing or administration of an antiarrhythmic drugAfter randomization all patients will be followed until the common study end date the last patient included in the study will be followed for 1 year Visits will be at baseline after 7 days after 14 days after one month after three months and then every three months until end of the study At each visit patients will be asked for the occurrence of hospitalizations or other events since the last visit The study will be monitored by an independent Data Monitoring Committee DMC for safety tolerability and efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None