The ATHENA trial is designed to assess whether dronedarone 400 mg bid prevents cardiovascular hospitalization or death from any cause in over 4,600 patients with atrial fibrillation or flutter.
RCT (n=4,600)
Double-blind
Parallel arm
Does dronedarone 400 mg bid reduce the time to first cardiovascular hospitalization or death from any cause in patients with a history of atrial fibrillation or atrial flutter compared to placebo?
The ATHENA trial is designed to evaluate the efficacy and safety of dronedarone 400 mg bid in preventing cardiovascular hospitalization or death in over 4,600 patients with atrial fibrillation or 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. CONCLUSION: 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 et al. (Wed,) conducted a rct in Atrial fibrillation or atrial flutter (n=4,600). Dronedarone vs. Placebo was evaluated on Time to first cardiovascular hospitalization or death from any cause. The ATHENA trial is designed to assess whether dronedarone 400 mg bid prevents cardiovascular hospitalization or death from any cause in over 4,600 patients with atrial fibrillation or flutter.