Clinical Trial

Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy

Study acronym: SAINT-FEXUDAPT
Recruiting
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Summary
This study evaluates whether fexuprazan is effective in preventing upper gastrointestinal bleeding and related upper gastrointestinal clinical events in high bleeding risk patients who require dual antiplatelet therapy after coronary stent implantation. A total of 400 participants at a single center will be randomly assigned in a 1:1 ratio within 48 hours after stent implantation to receive either fexuprazan 40 milligrams or lansoprazole 30 milligrams once daily for 6 months. The study will compare upper gastrointestinal clinical events during follow-up
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-13.
Trial Details
NCT Number NCT07479056
Lead Sponsor SUK MIN SEO
Collaborators: Daewoong Pharmaceutical Co. LTD.
Conditions Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD)
Enrollment 400 participants
Start Date 2024-10-24
Primary Completion 2028-04-30 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-08