Potassium-competitive acid blocker vs proton-pump inhibitor in patients receiving antithrombotic therapy who are at high risk for gastrointestinal bleeding: Rationale and design of the randomized PROTECT- HBR trial
Study context
- Population
- Patients with known cardiac or vascular disease receiving antithrombotic drugs (either antiplatelet or anticoagulant agents) who are at high risk of gastrointestinal (GI) bleedingplanned randomization, ≈1460 enrolled as of December 2024 from 32 sites in South Korea
- Participants
- ≈3,320 patients
- Planned comparison
- Potassium-competitive acid blocker (P-CAB) or proton pump inhibitor (PPI)
- Primary endpoint
- Composite outcome of:
- Upper GI clinical events
- Including overt or occult GI bleeding
- Symptomatic gastroduodenal ulcers or erosions
- Obstruction
- Perforation
- Follow-up
- 12 months
Methodological detailsrationale and design
- Rationale and design
No results yet. This paper sets out the design of a trial; its results are to come.
Further findings
Enrollment status · As of December 2024
- Patients enrolled
- ≈1460
- Participating sites in South Korea
- 32
- Complete enrollment anticipated at the mid- or late-term of 2025
Original publication
Potassium-competitive acid blocker vs proton-pump inhibitor in patients receiving antithrombotic therapy who are at high risk for gastrointestinal bleeding: Rationale and design of the randomized PROTECT- HBR trial. Am Heart J. Published 4 April 2025. doi:10.
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