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ATHENA: A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00174785
  Purpose

The primary efficacy parameter is the combined endpoint of cardiovascular hospitalization and death. Secondary efficacy parameters are death of any cause, cardiovascular death, cardiovascular hospitalization and non-cardiovascular hospitalization.


Condition Intervention Phase
Atrial Fibrillation
Atrial Flutter
Drug: dronedarone (SR33589)
Drug: placebo
Phase III

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
Drug Information available for: Dronedarone
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official 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)

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • The primary efficacy variable will be the time from randomization to death from any cause or hospitalization for cardiovascular reason, whichever is earlier.

Secondary Outcome Measures:
  • Secondary criteria are: Death from any cause, Cardiovascular death, Hospitalization for cardiovascular reasons

Enrollment: 4628
Study Start Date: June 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: dronedarone (SR33589)
2: Placebo Comparator Drug: placebo

Detailed Description:

This is a prospective, multinational, double-blind, randomized, multi-center, placebo-controlled, parallel-group trial evaluating the effects of dronedarone 400 mg BID 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 wil be monitored by an independent DMC for safety, tolerability and efficacy.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Patients aged 75 years or older, or patients aged at least 70 years 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.
  • 2. Availability of one 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.

Exclusion Criteria:

General criteria:

  • E1. Refusal or inability to give informed consent to participate in the study.
  • E2. Any non cardiovascular illness or disorder that could preclude participation or severely limit survival including cancer with metastasis and organ transplantation requiring immune suppression
  • E3. 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.
  • E4. Breastfeeding women
  • E5. Previous (2 preceding months) or current participation in another clinical trial with an investigational drug (under development) or with an investigational device.
  • E6. Previous participation in this trial.

Criteria Related to a cardiac condition:

  • E7. Patients in permanent atrial fibrillation
  • E8. 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
  • E9. 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
  • E10. Acute myocarditis or constrictive pericarditis
  • E11. Bradycardia < 50 bpm and/or PR-interval > 0.28 sec on the last 12-lead ECG.
  • E12. 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:

  • E13. 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 - see Section 8.9.1.

Criteria Related to Laboratory Abnormalities:

  • E14. Plasma potassium < 3.5 mmol/l (as anti-arrhythmic drugs can be arrhythmogenic in patients with hypokalemia, this must be corrected prior to randomization).
  • E15. A calculated GFR at baseline <10 ml/min using the Cockroft Gault formula
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174785

  Show 36 Study Locations
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: ICD CSD Sanofi-Aventis
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: sanofi-aventis ( ICD Study Director )
Study ID Numbers: EFC5555
Study First Received: September 13, 2005
Last Updated: June 2, 2008
ClinicalTrials.gov Identifier: NCT00174785  
Health Authority: United States: Food and Drug Administration;   Netherlands: Medicines Evaluation Board (MEB);   France: Afssaps - French Health Products Safety Agency

Keywords provided by Sanofi-Aventis:
Mortality, Hospitalization

Study placed in the following topic categories:
Death
Heart Diseases
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009