A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation (ATHENA)

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00174785

First received: September 13, 2005

Last updated: January 5, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

January 5, 2010

Start Date ^ICMJE

June 2005

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 ] [ Designated as safety issue: No ]

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

Death From Any Cause [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ] [ Designated as safety issue: No ]
First Hospitalization for Cardiovascular Reason [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ] [ Designated as safety issue: No ]
Cardiovascular Death [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Secondary criteria are:
- Death from any cause
- Cardiovascular death
- Hospitalization for cardiovascular reasons

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.

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Atrial Fibrillation
Atrial Flutter

Intervention ^ICMJE

Drug: dronedarone (SR33589)
oral administration (tablets)

Other Name: Multaq®
Drug: placebo
oral administration (tablets)

Study Arm (s)

Experimental: Dronedarone 400mg bid
Dronedarone 400mg tablets twice daily (bid)

Intervention: Drug: dronedarone (SR33589)
Placebo Comparator: Placebo
matching placebo tablets

Intervention: Drug: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

4628

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

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

Gender

Both

Ages

70 Years and older (Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States, 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

Removed Location Countries

France

Administrative Information

NCT Number ^ICMJE

NCT00174785

Other Study ID Numbers ^ICMJE

EFC5555

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

International Clinical Development - Study Director, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

International Clinical Development

Sanofi

Information Provided By

Sanofi

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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