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.
BACKGROUND
Atrial fibrillation (AF) is the most commonly encountered clinical arrhythmia, predominantly affecting elderly patients. There is a continued need for new antiarrhythmic drugs to treat the ever-increasing number of patients with this arrhythmia. Dronedarone is a new antiarrhythmic compound currently being developed for treatment of AF.


METHODS
The ATHENA trial (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) is the largest single antiarrhythmic drug trial ever conducted. More than 4,600 patients with a history of AF or atrial flutter (AFL) have been randomized to receive dronedarone 400 mg bid or matching placebo. The primary study endpoint is time to first cardiovascular hospitalization or death from any cause. The study has completed patient enrollment in December 2006 and is expected to end follow-up 1 year later.


CONCLUSIONS
ATHENA will be the largest efficacy and safety trial of dronedarone, a multichannel blocker compound with properties from class I, II, III, and IV antiarrhythmic drugs developed to treat patients with AF.
Hohnloser
Stefan H
SH
J. W. Goethe University, Department of Cardiology, Frankfurt, Germany. Hohnloser@em.uni-frankfurt.de
Connolly
Stuart J
SJ
Crijns
Harry J G M
HJ
Page
Richard L
RL
Seiz
Werner
W
Torp-Petersen
Christian
C
D000638:Amiodarone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage; D001281:Atrial Fibrillation / Q000401:mortality* / Q000517:prevention & control*; D004311:Double-Blind Method; D000077764:Dronedarone; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D038622:Internationality; D015990:Placebo Effect; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome
D000889:Anti-Arrhythmia Agents; D000077764:Dronedarone; D000638:Amiodarone