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RECRUITING
NCT07479056
NA

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

Sponsor: SUK MIN SEO

View on ClinicalTrials.gov

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

Official title: Randomized Active-Controlled Trial Evaluating Fexuprazan for Prevention Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy After Coronary Intervention-Fexuprazan for Patients With Dual Antiplatelet Therapy Trial

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2024-10-24

Completion Date

2028-12-31

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Fexuprazan 40mg

Fexuprazan 40 mg orally once daily + Lansoprazole placebo Matching placebo orally once daily.

DRUG

Lansoprazole 30mg

Lansoprazole 30 mg orally once daily. + Fexuprazan placebo Matching placebo orally once daily.

Locations (1)

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, South Korea