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NCT07479056
Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy
Conditions: Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD)
Sex: All
Ages: 20 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: SUK MIN SEO
Location: The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul Eunpyeong-gu
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 200 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
Eligibility Criteria
Inclusion Criteria:
* All four conditions below must be met.
1. Patients who are 20 years of age or older, have undergone coronary artery stent implantation for coronary artery disease, and require dual antiplatelet therapy for 6 months or longer.
2. Patients are considered to be at high bleeding risk if at least 1 criteria are met (Based on clinical recommendations (6,7,10,14-16) and expert consensus documents (17-19)) 1) Age ≥65 y 2) Low body weight (\
Source: ClinicalTrials.gov (NCT07479056). StuddyBuddy aggregates publicly available trial information.