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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00174785
Registration number
NCT00174785
Ethics application status
Date submitted
13/09/2005
Date registered
15/09/2005
Date last updated
12/01/2010
Titles & IDs
Public title
A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation
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Scientific title
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)
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Secondary ID [1]
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EFC5555
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Universal Trial Number (UTN)
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Trial acronym
ATHENA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
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Atrial Flutter
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Cardiovascular
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - dronedarone (SR33589)
Treatment: Drugs - placebo
Experimental: Dronedarone 400mg bid - Dronedarone 400mg tablets twice daily (bid)
Placebo Comparator: Placebo - matching placebo tablets
Treatment: Drugs: dronedarone (SR33589)
oral administration (tablets)
Treatment: Drugs: placebo
oral administration (tablets)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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First Hospitalization for Cardiovascular Reason or Death From Any Cause
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Assessment method [1]
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The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
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Timepoint [1]
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minimum follow-up duration: 1 year ; maximum: 2.5 years
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Secondary outcome [1]
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Death From Any Cause
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Assessment method [1]
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The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
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Timepoint [1]
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minimum follow-up duration: 1 year ; maximum: 2.5 years
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Secondary outcome [2]
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First Hospitalization for Cardiovascular Reason
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Assessment method [2]
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The considered event is the first hospitalization for cardiovascular reason, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
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Timepoint [2]
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minimum follow-up duration: 1 year ; maximum: 2.5 years
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Secondary outcome [3]
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Cardiovascular Death
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Assessment method [3]
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The considered event is cardiovascular death, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
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Timepoint [3]
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minimum follow-up duration: 1 year ; maximum: 2.5 years
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Eligibility
Key inclusion criteria
- 1. Patients aged 75 years or older (70 years before protocol amendment 1), or patients
aged at least 70 years (any age before protocol amendment 1) with one or more of the
following risk factors at baseline:
- Hypertension (taking antihypertensive drugs of at least two different classes)
- Diabetes
- Prior cerebrovascular accident (stroke or transient ischemic attack) or systemic
embolism
- Left atrium diameter greater than or equal to 50 mm by echocardiography
- Left ventricular ejection fraction less than 0.40 by 2D-echocardiography
(two-dimensional echocardiography)
- 2. Availability of one electrocardiogram (ECG) within the last 6 months, showing that
the patient was or is in AF/AFL
- 3. Availability of one ECG within the last 6 months, showing that the patient was or
is in sinus rhythm
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Minimum age
70
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
General criteria:
- 1. Refusal or inability to give informed consent to participate in the study
- 2. Any non cardiovascular illness or disorder that could preclude participation or
severely limit survival including cancer with metastasis and organ transplantation
requiring immune suppression
- 3. Pregnant women (pregnancy test must be negative) or women of childbearing potential
not on adequate birth control: only women with a highly effective method of
contraception [oral contraception or intra-uterine device (IUD)] or sterile can be
randomized.
- 4. Breastfeeding women
- 5. Previous (2 preceding months) or current participation in another clinical trial
with an investigational drug (under development) or with an investigational device
- 6. Previous participation in this trial
Criteria Related to a cardiac condition:
- 7. Patients in permanent atrial fibrillation
- 8. Patients in unstable hemodynamic condition such as acute pulmonary edema within 12
hours prior to start of study medication; cardiogenic shock; treatment with
intra-venous pressor agents; patients on respirator; congestive heart failure of stage
NYHA IV (New York Heart Association classification) within the last 4 weeks;
uncorrected, hemodynamically significant primary obstructive valvular disease;
hemodynamically significant obstructive cardiomyopathy; a cardiac operation or
revascularization procedure within 4 weeks preceding randomization
- 9. Planned major non-cardiac or cardiac surgery or procedures including surgery for
valvular heart disease, coronary artery bypass graft (CABG) , percutaneous coronary
intervention (PCI) , or on urgent cardiac transplantation list
- 10. Acute myocarditis or constrictive pericarditis
- 11. Bradycardia < 50 bpm and/or PR-interval > 0.28 sec on the last 12-lead ECG
- 12. Significant sinus node disease (documented pause of 3 seconds or more) or 2nd or
3rd degree atrioventricular block (AV-block) unless treated with a pacemaker
Criteria Related to Concomitant Medications:
- 13. Need of a concomitant medication that is prohibited in this trial, including the
requirement for Vaughan Williams Class I and III anti-arrhythmic drugs, that would
preclude the use of study drug during the planned study period
Criteria Related to Laboratory Abnormalities:
- 14. Plasma potassium < 3.5 mmol/l (as anti-arrhythmic drugs can be arrhythmogenic in
patients with hypokalemia, this must be corrected prior to randomization)
- 15. A calculated Glomerular Filtration Rate (GFR) at baseline <10 ml/min using the
Cockroft Gault formula
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2008
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Sample size
Target
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Accrual to date
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Final
4628
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sanofi-Aventis Administrative Office - New South Wales
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Recruitment postcode(s) [1]
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- New South Wales
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Recruitment outside Australia
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United States of America
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New Jersey
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Argentina
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Buenos Aires
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Austria
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Wien
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Diegem
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Laval
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Chile
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Santiago
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China
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Shangaï
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Czech Republic
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Praha
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Finland
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Helsinki
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Germany
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Berlin
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Greece
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Athens
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Hong Kong
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Causeway Bay
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Hungary
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Budapest
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India
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Mumbai
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Israel
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Natanya
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Milano
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Gouda
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Warszawa
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Porto Salvo
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Moscow
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Singapore
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Midrand
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Barcelona
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Sweden
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Bromma
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Taipei
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Bangkok
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Tunisia
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Megrine
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Turkey
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Istanbul
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United Kingdom
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Guildford Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Ethics approval
Ethics application status
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Summary
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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Trial website
https://clinicaltrials.gov/ct2/show/NCT00174785
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Trial related presentations / publications
Hohnloser SH, Connolly SJ, Crijns HJ, Page RL, Seiz W, Torp-Petersen C. Rationale and design of ATHENA: A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter. J Cardiovasc Electrophysiol. 2008 Jan;19(1):69-73. doi: 10.1111/j.1540-8167.2007.01016.x. Epub 2007 Nov 21.
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Public notes
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Contacts
Principal investigator
Name
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International Clinical Development
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Address
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Sanofi
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00174785
Download to PDF