Valvular & structural heart disease
Study design and rationale of COMPETE: Comparison of the effect of medication therapy in alleviating migraine with patent foramen ovale
Study context
- Population
- Migraine patients with a right-to-left shunt at the atrial level (Patent Foramen Ovale (PFO))planned
- Participants
- 1,000 patients
- Planned comparison
- Antithrombotic agents vs first-line migraine medication
- Primary endpoint
- Response rate: ≥50% reduction in average migraine attack days per month or average number of migraine attacks per month vs baseline
- Follow-up
- 12-week visit
Methodological detailsinvestigator-initiated, multicentre, single-masked (outcomes assessor), active-controlled, parallel-group, 1:1:1:1 randomisation
- Investigator-initiated
- Multicentre
- Single-masked (outcomes assessor)
- Active-controlled
- Parallel-group
- 1:1:1:1 randomisation
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Study design and rationale of COMPETE: Comparison of the effect of medication therapy in alleviating migraine with patent foramen ovale. Am Heart J. Published 16 December 2023. doi:10.
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