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

Summary

Participation Requirements

Description

Before randomization phase, one lead-in subject (N = 300 patients) will be enrolled to perform safety surveillance of standard-dose tegoprazan (50 mg for 6 months) and to ensure the safety of tegoprazan (safety surveillance phase). Data on lead-in subjects will not be included in the data set used f...

Before randomization phase, one lead-in subject (N = 300 patients) will be enrolled to perform safety surveillance of standard-dose tegoprazan (50 mg for 6 months) and to ensure the safety of tegoprazan (safety surveillance phase). Data on lead-in subjects will not be included in the data set used for primary analyses. The safety of tegoprazan will be estimated SIAEs(Special Interest Adverse Events) as follows; Composite Event liver function abnormalities hypergastrinemia, or enteric infection Definitions liver function abnormality: defined as AST or ALT>3× upper limit of normal or two consecutive measurements of total bilirubin >2 x upper limit of normal hypergastrinemia enteric infection including C.difficile infection If there are any new tegoprazan-related findings, it will be considered in the estimation. If there is no safety concern during safety surveillance phase, investigator-driven, randomized, double-blind, double-dummy, active-controlled, clinical trial (N = 3,000 patients) will be subsequently performed (randomization phase).

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