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NCT04416581 · ClinicalTrials.gov record · last posted 2026-06-26

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

Study acronym: PROTECT-HBR
StatusRecruiting
PhasePhase 4
Started2021-05-12
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from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-06-27
critical
Primary completion pushed: 2026-09-30 → 2027-12-31
2026-06-27
minor
Completion pushed: 2027-12-31 → 2028-02-28
Trial Details
NCT Number NCT04416581
Lead Sponsor Duk-Woo Park, MD
Conditions Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome, Myocardial Infarction
Enrollment 3,320 participants
Start Date 2021-05-12
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-26