New stomach drug may protect heart patients from dangerous bleeding
NCT ID NCT07479056
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if fexuprazan can prevent upper stomach bleeding in 400 heart patients at high risk for bleeding who must take two blood thinners after getting a heart stent. Participants receive either fexuprazan or the standard drug lansoprazole daily for 6 months. The goal is to see which drug better prevents bleeding, ulcers, and other stomach issues.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 (\<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 3. 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. 4. 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. * Medically valid contraceptive methods: intrauterine device (Loop, Mirena), physical barrier method (male condom, female condom (femidom)), subcutaneous contraception (Implanon, etc.), long-acting contraceptive injection, or tubectomy and ligation, vasectomy, etc. ( However, oral contraceptives cannot be used during this clinical trial, and it is recommended to use double contraception to prevent pregnancy while participating in this trial.) Exclusion Criteria: 1. 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 2. Patients with contraindications to antiplatelet agents, such as allergies. 3. Genetic blood coagulation disorders 4. 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. 5. Hemodynamically unstable at the time of randomization (cardiogenic shock, uncontrolled arrhythmia, severe heart failure: NYHA Class IV). 6. Patients with warning symptoms suspected of digestive malignancy (unintentional significant weight loss, recurrent vomiting, dysphagia, hematemesis, melena, etc.) within the past 3 months 7. Patients with malignancy or serious illnesses with an expected survival of less than 1 year. 8. Severe anemia (hemoglobin \< 8 g/dL) or blood transfusion within 4 weeks of randomization. 9. Active liver disease or impaired liver function (AST or ALT greater than three times the upper limit of normal). 10. Advanced renal dysfunction: eGFR less than 30 mLmin/1.73m2 or patients receiving dialysis 11. Patients taking drugs contraindicated for this clinical trial drug (e.g., patients taking atazanavir, nelfinavir, or rilpivirine-containing preparations) 12. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 13. Concurrently taking CYP 3A4 and p-glycoprotein (P-GP) inhibitors. 14. Dementia or individuals unable to understand the trial procedures or comply with the trial requirements 15. Pregnant or breastfeeding women, or women planning to become pregnant 16. Individuals with active infections, significant hematologic, renal, metabolic, gastrointestinal, endocrine disorders, or any other reason the investigator deems the subject unsuitable for participation in the clinical trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Catholic University of Korea, Eunpyeong St. Mary's Hospital
RECRUITINGSeoul, Eunpyeong-gu, 03312, South Korea
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