Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT07479056

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

Led by SUK MIN SEO · Updated on 2026-04-08

400

Participants Needed

1

Research Sites

218 weeks

Total Duration

On this page

Sponsors

S

SUK MIN SEO

Lead Sponsor

D

Daewoong Pharmaceutical Co. LTD.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 20 years or older who have undergone coronary artery stent implantation for coronary artery disease and require dual antiplatelet therapy for 6 months or more
  • Patients at high bleeding risk with at least one of the following: age 65 or older, low body weight (<55 kg for men, <50 kg for women), hemoglobin <11 g/dL, platelet count <100 x10^9/L, severe chronic kidney disease (eGFR <30 mL/min/1.73m2) or on hemodialysis, anticipated long-term use of oral anticoagulants, long-term use of oral NSAIDs or steroids, heart failure, history of gastric or duodenal ulcer, history of gastrointestinal bleeding, or previous or confirmed Helicobacter pylori infection
  • Voluntary participants who have provided written informed consent or whose legal guardians have provided consent
  • Participants who agree to use medically valid contraception during the trial period, or women medically unable to become pregnant (e.g., menopause, hysterectomy, salpingectomy, or bilateral oophorectomy)
Not Eligible

You will not qualify if you...

  • History of hypersensitivity to the study drug components or benzimidazole-based drugs
  • Contraindications or allergies to antiplatelet agents
  • Genetic blood coagulation disorders
  • Severe liver cirrhosis, thrombocytopenia, or other conditions making dual antiplatelet therapy difficult
  • Hemodynamic instability at randomization (e.g., cardiogenic shock, uncontrolled arrhythmia, severe heart failure NYHA Class IV)
  • Symptoms suggesting digestive malignancy within the past 3 months (e.g., significant weight loss, recurrent vomiting, dysphagia, hematemesis, melena)
  • Malignancy or serious illness with expected survival less than 1 year
  • Severe anemia (hemoglobin <8 g/dL) or blood transfusion within 4 weeks before randomization
  • Active liver disease or significant liver function impairment (AST or ALT >3 times upper limit)
  • Advanced renal dysfunction (eGFR <30 mL/min/1.73m2) or dialysis
  • Use of contraindicated drugs (e.g., atazanavir, nelfinavir, rilpivirine-containing drugs)
  • Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • Concurrent use of CYP 3A4 and P-glycoprotein inhibitors
  • Dementia or inability to understand or comply with trial procedures
  • Pregnant, breastfeeding, or planning pregnancy
  • Active infections or significant hematologic, renal, metabolic, gastrointestinal, or endocrine disorders or other conditions making participation unsuitable

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Seoul, Eunpyeong-gu, South Korea, 03312

Actively Recruiting

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Research Team

S

SUK MIN SEO, MD, PhD

CONTACT

Y

YUN JU KANG, CRC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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