Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation

Summary

Primary Objective: \- Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization according to different timings of initiation of dronedarone. Secondary Objective: * Evaluate the rate of AF recurrences two months after randomization. * Assess the safety of the change from amiodarone to dronedarone * Assess dronedarone safety * Explore dronedarone and its active metabolite plasma level (in a subset of countries) * Explore potential Pharmacokinetic (PK) interaction between dronedarone and amiodarone (in a subset of countries)

Timeline

Start

2010-09

Primary completion

2011-12

Completion

2011-12

Outcome

Missed primary endpoint

paper Atrial fibrillation recurrence trended less in the immediate switch versus 4-week washout group (hazard ratio [HR] = 0.65 [97.5% CI: 0.34-1.23]; P = .14) PMID 32500725 ↗

Publications

• Naccarelli GV, Bhatt DL, Camm AJ, Le Heuzey JY, Lombardi F, Tamargo J, Martinez JM, Naditch-Brule L; ARTEMIS AF Investigators. Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies. J Cardiovasc Pharmacol Ther. 2020 Sep;25(5):425-437. doi: 10.1177/1074248420926874. Epub 2020 Jun 5.

Drugs

Indications