Potassium-competitive acid blocker versus 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
Abstract
BACKGROUND
Concomitant use of proton pump inhibitor (PPI) is recommended in patients receiving chronic antithrombotic therapy who are at high risk of gastrointestinal (GI) bleeding. However, long-term safety and efficacy of chronic PPI use have been concerned. Potassium-competitive acid blocker (P-CAB) is a novel class of acid suppressants, providing more acid stability, rapid onset of action, less variability with CYP2C19 polymorphisms, and longer duration of action than PPI.
DESIGN
The PROTECT-HBR trial is a multicenter, randomized, double-blind, double-dummy, parallel-group clinical trial. Approximately 3320 patients with known cardiac or vascular disease receiving antithrombotic drugs (either antiplatelet or anticoagulant agents) and who are at high risk of GI bleeding will be randomized to P-CAB (tegoprazan 50mg once daily) or PPI (rabeprazole 20mg once daily) for up to 12 months. The primary endpoint is a composite outcome of upper GI clinical events, including overt or occult GI bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation, at 12 months. Secondary endpoints also included cardiovascular events and safety outcomes.
RESULTS
As of December 2024, approximately 1460 patients were enrolled from 32 participating sites in South Korea. The complete enrollment is anticipated at the mid- or late-term of 2025, and the primary results will be available by 2027.
CONCLUSION
PROTECT-HBR is a large-scale, multicenter, clinical trial, which will…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 3,320 participants or records.
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