NCT00174785|CompletedPhase 3ResultsDMC

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

ATHENA

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)

Sanofi ClinicalTrials.gov

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1 other identifier

EFC5555

Study Type

interventional

Target

4,628

Locations

35 countries

Sites

Timeline

RegisteredSep 2005

StartedJun 2005

CompletionMar 2008

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

4,628

participants targeted

Target at P75+ for phase_3 atrial-fibrillation

Timeline

Completed

Started Jun 2005

Geographic Reach

35 countries

35 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

June 1, 2005

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

December 23, 2009

Completed

Last Updated

January 12, 2010

Status Verified

January 1, 2010

Enrollment Period

2.8 years

First QC Date

September 13, 2005

Results QC Date

July 24, 2009

Last Update Submit

January 5, 2010

Conditions

Atrial Fibrillation Atrial Flutter

Keywords

Mortality, Hospitalization

Outcome Measures

Primary Outcomes (1)

First Hospitalization for Cardiovascular Reason or Death From Any Cause
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.
minimum follow-up duration: 1 year ; maximum: 2.5 years

Secondary Outcomes (3)

Death From Any Cause
minimum follow-up duration: 1 year ; maximum: 2.5 years
First Hospitalization for Cardiovascular Reason
minimum follow-up duration: 1 year ; maximum: 2.5 years
Cardiovascular Death
minimum follow-up duration: 1 year ; maximum: 2.5 years

Other Outcomes (1)

Adjudicated Cardiovascular Death
minimum follow-up duration: 1 year ; maximum: 2.5 years

Study Arms (2)

Dronedarone 400mg bid

EXPERIMENTAL

Dronedarone 400mg tablets twice daily (bid)

Drug: dronedarone (SR33589)

Placebo

PLACEBO COMPARATOR

matching placebo tablets

Drug: placebo

Interventions

dronedarone (SR33589)DRUG

oral administration (tablets)

Also known as: Multaq®

Dronedarone 400mg bid

placeboDRUG

oral administration (tablets)

Placebo

Eligibility Criteria

Age70 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

\. 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)
\. Availability of one electrocardiogram (ECG) within the last 6 months, showing that the patient was or is in AF/AFL
\. Availability of one ECG within the last 6 months, showing that the patient was or is in sinus rhythm

You may not qualify if:

General criteria:
\. Refusal or inability to give informed consent to participate in the study
\. Any non cardiovascular illness or disorder that could preclude participation or severely limit survival including cancer with metastasis and organ transplantation requiring immune suppression
\. 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.
\. Breastfeeding women
\. Previous (2 preceding months) or current participation in another clinical trial with an investigational drug (under development) or with an investigational device
\. Previous participation in this trial
Criteria Related to a cardiac condition:
\. 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 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
\. 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
\. Acute myocarditis or constrictive pericarditis
\. Bradycardia \< 50 bpm and/or PR-interval \> 0.28 sec on the last 12-lead ECG
\. 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:
+4 more criteria

Contact the study team to confirm eligibility.