Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy

Summary

The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB (tegoprazan 50 mg once daily) as compared with standard PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with known cardiac and vascular disease receiving chronic use of antithrombotic drugs (either antiplatelets, OAC, and its combinations) who are at high GI bleeding risk. The primary hypothesis is that P-CAB (experimental arm) would non-inferior to PPI (standard arm) with respect to the rate of the primary composite end point of GI events at 12 months after randomization.

Timeline

Start

2021-05-12

Primary completion

2027-12-31

Completion

2028-02-28

Publications

• Lee J, Park HS, Lee J, Choi KD, Kang DY, Ahn JM, Kim W, Lee JY, Lim YH, Kang SH, Kwon SU, Park H, Choi EK, Hong SJ, Kim BK, Jin ES, Jeong JO, Nam CW, Lee WS, Kim SM, Park KH, Her SH, Shin ES, Choi YJ, Yang TH, Kim SH, Suh JW, Park HC, Yoon YH, Yoon MH, Park SJ, Park DW; PROTECT-HBR Trial. 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. 2025 Sep;287:50-60. doi: 10.1016/j.ahj.2025.04.001. Epub 2025 Apr 4.

Drugs

Indications