Arrhythmias & electrophysiology
Design and rationale of a pragmatic randomized clinical trial of early dronedarone versus usual care to change and improve outcomes in persons with first-detected atrial fibrillation – the CHANGE AFIB study
Study context
- Population
- Patients with first-detected atrial fibrillation (AF)planned ≈3,000
- Planned comparison
- Dronedarone plus usual care vs usual care alone
- Primary endpoint
- Time to first CV hospitalization or all-cause death
- Follow-up
- 12 months from randomization
Methodological detailsdesign and rationale, open-label, pragmatic, nested within the Get with The Guidelines Atrial Fibrillation registry, 1:1 randomisation, ≈200 sites, Planned secondary endpoints: WIN ratio (all-cause death, ischemic stroke or systemic embolism, HF hospitalization, acute coronary hospitalization), cardiovascular (CV) hospitalization, all-cause mortality, Patient-reported outcomes: change in AFEQT and MAFSI from baseline to 12 months
- Design and rationale
- Open-label
- Pragmatic
- Nested within the Get with The Guidelines Atrial Fibrillation registry
- 1:1 randomisation
- ≈200 sites
- Planned secondary endpoints: WIN ratio (all-cause death, ischemic stroke or systemic embolism, HF hospitalization, acute coronary hospitalization), CV hospitalization, all-cause mortality
- Patient-reported outcomes: change in AFEQT and MAFSI from baseline to 12 months
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Design and rationale of a pragmatic randomized clinical trial of early dronedarone versus usual care to change and improve outcomes in persons with first-detected atrial fibrillation – the CHANGE AFIB study. Am Heart J. Published 16 October 2024. doi:10.
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