Arrhythmias & electrophysiologyTrial design
Design and rationale of the GUARD-OAC: A randomized controlled trial evaluating proton pump inhibitor cotherapy for gastrointestinal protection in patients requiring direct oral anticoagulants
- prospective, multicenter, open-label, randomized controlled trial
Study context
- Population
- Patients with cardio- or cerebrovascular disease requiring long-term anticoagulation (≥1 year), currently receiving or initiating DOAC therapy, with a HAS-BLED score of ≥1planned enrolment, followed for one year
- Participants
- 3,846 patients
- Planned comparison
- PPI plus DOAC group compared to the DOAC alone group
- Primary endpoint
- Composite of:
- Upper gastrointestinal (GI) clinical events
- Including bleeding
- Symptomatic gastroduodenal ulcer
- Persistent pain of presumed GI origin with underlying multiple erosive disease
- Obstruction
- Perforation
- Follow-up
- One year
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Design and rationale of the GUARD-OAC: A randomized controlled trial evaluating proton pump inhibitor cotherapy for gastrointestinal protection in patients requiring direct oral anticoagulants. Am Heart J. Published 6 January 2026. doi:10.1016/j.ahj.2026.107341
Summarised from the published abstract; every number is checked against it