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Register:	EUCTR
Last refreshed on:	12 June 2012
Main ID:	EUCTR2005-000715-98-PT
Date of registration:	11/11/2005
Prospective Registration:	Yes
Primary sponsor:	Sanofi-Synthelabo Recherche
Public title:	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 (AF/AFL) - ATHENA
Scientific title:	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 (AF/AFL) - ATHENA
Date of first enrolment:	30/11/2005
Target sample size:	3700
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000715-98
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:

Countries of recruitment
Czech Republic	Finland	Germany	Hungary	Italy	Norway	Portugal	Spain
Sweden	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
-One or more of the following risk factors must be present at the baseline :
age equal or greater than 70 years, hypertension (taking antihypertensive drugs of at least two different classes), diabetes, prior cerebrovascular accident or systemic embolism, left atrium diameter greater than or equal to 50 mm by echocardiography, left ventricular ejection fraction less than 0.4 by 2D echocardiography.
-Availibility of one ECG within the last 6 months, showing that the patient was or is in AF/AFL,
-Availibility of one ECG within the last 6 months showing that the patient was or is in sinus rhythm.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
-Any non cardiovascular illness or disorder that could preclude participation or severely limit survival.
-Pregnant women, women of child-bearing potential without adequat birth control, breast feeding women.
- Patients in permanent atrial fibrillation
- Patients in unstable hemodynamic condition such as acute pulmonary edema within 12 hours prior to start of study medication; cardiogenic shock; treatment with IV pressor agents; patients on respirator; congestive heart failure of stage NYHA IV 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
- Planned major non-cardiac or cardiac surgery or procedures
- Acute myocarditis or constrictive pericarditis
- Bradycardia < 50 bpm and/or PR-interval ³ 0.28 sec on the last 12-lead ECG.
- Significant sinus node disease or 2nd or 3rd degree atrioventricular block unless treated with a pacemaker
- Need of a concomitant medication that is prohibited in this trial
- Plasma potassium < 3.5 mmol/l
- A calculated GFR at baseline <10 ml/min (using the Cockroft Gault formula)

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

atrial fibrillation/atrial flutter
MedDRA version: 7.1 Level: LLT Classification code 10003658

Intervention(s)

Product Name: dronedarone
Product Code: SR33589B
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: dronedarone
CAS Number: 141625-93-6
Current Sponsor code: SR33589B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: To assess that dronedarone is well tolerated in this population

Main Objective: To assess the efficacy of dronedarone in preventing cardiovascular hospitalizations or death from any cause in a population of high risk patients with Atrial Fibrillation/Atrial FLutter (AF/AFL).

Primary end point(s): first occurence of hospitalization for cardiovascular reasons or death from any cause.

Secondary Outcome(s)

Secondary ID(s)

2005-000715-98-GB

EFC5555

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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