Arrhythmias & electrophysiology
The Seventh Prevention of Syncope Trial (POST VII)—A randomized clinical trial of atomoxetine for the prevention of vasovagal syncope: Rationale and study design
Study context
- Population
- Patients with vasovagal syncope and ≥2 syncopal spells in the preceding yearplanned
- Participants
- 180 patients
- Planned comparison
- Atomoxetine vs placebo
- Primary endpoint
- Proportion of patients with ≥1 syncope recurrence in each arm (ITT)
- Follow-up
- 6-month observation period per phase
Methodological detailsmulticentre, double-blind, placebo-controlled, crossover, 1-week washout between phases, Power: assuming 33% RR reduction in syncope recurrence and 16% dropout, 180 patients give 85% power, P = .05
- Multicentre
- Double-blind
- Placebo-controlled
- Crossover
- 1-week washout between phases
- Power: assuming 33% RR reduction in syncope recurrence and 16% dropout, 180 patients give 85% power, P = .05
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
The Seventh Prevention of Syncope Trial (POST VII)—A randomized clinical trial of atomoxetine for the prevention of vasovagal syncope: Rationale and study design. Am Heart J. Published 24 April 2023. doi:10. 1016/ j. ahj. 2023. 04. 012
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