A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation (ATHENA)
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ClinicalTrials.gov Identifier: NCT00174785 |
Recruitment Status
:
Completed
First Posted
: September 15, 2005
Results First Posted
: December 23, 2009
Last Update Posted
: January 12, 2010
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Tracking Information | ||||
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First Submitted Date ICMJE | September 13, 2005 | |||
First Posted Date ICMJE | September 15, 2005 | |||
Results First Submitted Date | July 24, 2009 | |||
Results First Posted Date | December 23, 2009 | |||
Last Update Posted Date | January 12, 2010 | |||
Study Start Date ICMJE | June 2005 | |||
Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
First Hospitalization for Cardiovascular Reason or Death From Any Cause [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ] | |||
Original Primary Outcome Measures ICMJE |
The primary efficacy variable will be the time from randomization to death from any cause or hospitalization for cardiovascular reason, whichever is earlier. | |||
Change History | Complete list of historical versions of study NCT00174785 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation | |||
Official Title ICMJE | A Placebo-controlled,Double-blind,Parallel 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 Fibrillation/Atrial Flutter (AF/AFL) | |||
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 fibrillation/atrial flutter (AF/AFL). To assess that dronedarone is well tolerated in this population. |
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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 1:1) over a minimum treatment duration of 12 months and a mean follow-up duration of 1.75 years (in AF/AFL patients). Patients can be included in the study while in atrial fibrillation/flutter 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 drug.After 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 Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
4628 | |||
Original Enrollment ICMJE |
3700 | |||
Actual Study Completion Date | March 2008 | |||
Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: General criteria:
Criteria Related to a cardiac condition:
Criteria Related to Concomitant Medications:
Criteria Related to Laboratory Abnormalities:
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Sex/Gender |
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Ages | 70 Years and older (Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czech Republic, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Russian Federation, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, United States | |||
Removed Location Countries | France | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00174785 | |||
Other Study ID Numbers ICMJE | EFC5555 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | International Clinical Development - Study Director, sanofi-aventis | |||
Study Sponsor ICMJE | Sanofi | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sanofi | |||
Verification Date | January 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |