Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Recei… (NCT07479056) | Clinical Trial Compass
RecruitingNot Applicable
Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy
South Korea400 participantsStarted 2024-10-24
Plain-language 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
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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 (\<55 Kg for men, \<50 Kg for women) 3)Hemoglobin \<11g/dL 4) Platelet count \<100×109/L 5) Severe CKD: eGFR \<30mL/min/1.73m2,5 or on hemodialysis 6) Anticipated use of long-term oral anticoagulation (warfarin or direct-acting oral anticoagulants) 7) Long-term use of oral NSAIDs or steroids 8) Heart failure 9) A history of previous gastric or duodenal ulcer. 10) A history of previous gastrointestinal bleeding. 11)Previous or confirmed Helicobacter pylori infection
✓. A voluntary participant in this clinical trial who has provided written consent, or a legal guardian who has provided written consent on behalf of the participant.
✓. Those who agree to use a medically valid method of contraception\* (including conditions in which pregnancy is medically impossible) during the clinical trial period Women who are medically unable to become pregnant can participate in this clinical trial: women who have undergone menopause (amenorrhea for more than 24 months), hysterectomy, salpingectomy, or bilateral oophorectomy, etc.
Exclusion criteria
What they're measuring
1
Time from randomization to first occurrence of a composite endpoint of upper gastrointestinal clinical events during the treatment period
✕. Patients who have a hypersensitivity reaction to the components of this clinical trial drug or benzimidazole-based drugs or have a history of clinically significant hypersensitivity reaction
✕. Patients with contraindications to antiplatelet agents, such as allergies.
✕. Genetic blood coagulation disorders
✕. Cases in which the investigator determines that the use of dual antiplatelet therapy is difficult due to severe liver cirrhosis, thrombocytopenia, or other medical conditions.
✕. Hemodynamically unstable at the time of randomization (cardiogenic shock, uncontrolled arrhythmia, severe heart failure: NYHA Class IV).
✕. Patients with warning symptoms suspected of digestive malignancy (unintentional significant weight loss, recurrent vomiting, dysphagia, hematemesis, melena, etc.) within the past 3 months
✕. Patients with malignancy or serious illnesses with an expected survival of less than 1 year.
✕. Severe anemia (hemoglobin \< 8 g/dL) or blood transfusion within 4 weeks of randomization.