Study of Fexuprazan to Prevent Upper Gastrointestinal Bleeding in Patients at High Bleeding Risk on Dual Antiplatelet Therapy After Coronary Stent Placement

What this Trial Is About

Researchers are evaluating whether fexuprazan can prevent upper gastrointestinal bleeding and related clinical events in patients at high risk of bleeding who require dual antiplatelet therapy after coronary stent implantation. This study focuses on patients with coronary artery disease who have undergone stent placement and are at increased risk of bleeding due to their treatment and other factors. The trial addresses concerns about bleeding risks associated with current treatments and the need for better protective options. Participants will be randomly assigned within 48 hours after stent implantation to receive either fexuprazan 40 mg or lansoprazole 30 mg once daily. Both groups will also receive matching placebos to maintain blinding. Treatment lasts for 6 months, and the study is designed as a double-blind, randomized, active-controlled trial comparing the effects of these two medications in preventing gastrointestinal bleeding. During the study, participants will be monitored for upper gastrointestinal clinical events and other health outcomes related to bleeding and heart conditions. Researchers will collect data on bleeding episodes, gastroesophageal reflux disease, myocardial infarction, stroke, and other cardiovascular events. Safety and symptom assessments, including a dyspepsia questionnaire, will be conducted over the 6-month treatment period to understand the impact of the medications on participants health.

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