Overview

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

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
The primary aim of this study is to evaluate the efficacy and safety of P-CAB (tegoprazan 50 mg once daily) as compared with PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with cardiovascular disease receiving antiplatelet and oral anticoagulant therapy who are at high GI bleeding risk. The primary hypothesis is that P-CAB (experimental arm) is non-inferior to PPI (standard arm) with respect to the rate of the primary composite endpoint of GI events at 6 months. In addition, as exploratory nature, we evaluate the efficacy and safety of low-dose P-CAB (tegoprazan 25 mg once daily) as compared with standard-dose P-CAB (tegoprazan 50 mg once daily) and standard-dose PPI (rabeprazole 20 mg).
Phase:
Phase 4
Details
Lead Sponsor:
Duk-Woo Park, MD