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RecruitingNCT07479056SAINT-FEXUDAPTUpdated Apr 8, 2026

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

An interventional study of Fexuprazan 40mg and Lansoprazole 30mg in Acute Coronary Syndromes (ACS) and Coronary Artery Disease (CAD), sponsored by SUK MIN SEO. Recruiting at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by SUK MIN SEO · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Oct 2024, registered Mar 2026).
  • Started Oct 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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

Read the detailed description

The use of antiplatelet agents inevitably increases the risk of bleeding, which is associated with increased mortality. Gastrointestinal bleeding, including upper gastrointestinal bleeding, is the most common bleeding complication, accounting for approximately two-thirds of bleeding events associated with dual antiplatelet therapy (DAPT). The use of proton pump inhibitors (PPIs) has been investigated to reduce the risk of gastrointestinal bleeding, and the Clopidogrel and the Optimization of Gastrointestinal Events Trial (COGENT) was the only large study to report a reduction in gastrointestinal bleeding with PPI use. However, smaller randomized trials and meta-analyses have reported conflicting results regarding the efficacy of PPI use. In addition, PPIs require caution when used in conjunction with P2Y12 inhibitors such as clopidogrel, as they may reduce antiplatelet activity and increase the risk of thrombotic events.

Currently, European clinical guidelines recommend prescribing PPIs as gastrointestinal protective agents to all patients, whereas American College of Cardiology Foundation, American College of Cardiology, and American Heart Association (ACCF/ACC/AHA) clinical guidelines recommend prescribing PPIs only to patients at high risk of upper gastrointestinal bleeding rather than universal use. With an increase in coronary stenting among elderly and high-risk patients with coronary artery disease, the population at high risk of bleeding is also increasing. Approximately 20 percent of patients were identified as being at high risk of bleeding within 1 year after coronary artery intervention according to Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding criteria. Additionally, East Asians, including Koreans, are known to be at higher risk of upper gastrointestinal bleeding because of various genetic and environmental factors. Therefore, efforts to prevent gastrointestinal bleeding during the period of DAPT after stent insertion are increasingly important.

Potassium-competitive acid blockers (P-CABs) are a new class of hydrogen/potassium adenosine triphosphatase (H+/K+ ATPase) inhibitors used to treat gastrointestinal acid-related disorders such as gastroesophageal reflux disease, peptic ulcers, and Helicobacter pylori infections. Unlike PPIs, which bind to the proton pump, P-CABs competitively and reversibly inhibit the potassium site of H+/K+ ATPase, leading to relatively long-lasting inhibition of acid secretion. Fexuprazan (Fexuclue) has demonstrated efficacy in phase 3 clinical trials in patients with erosive esophagitis and has been shown to have a faster onset of action than esomeprazole and sustained acid suppression throughout the night. Therefore, this double-blind, randomized, active-controlled study was designed to evaluate the preventive effect of fexuprazan on upper gastrointestinal events in high-risk patients who require DAPT.

A total of 400 participants at a single center will be enrolled. Eligible participants 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

02

Conditions studied

  • Acute Coronary Syndromes (ACS)
  • Coronary Artery Disease (CAD)
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's planned enrollment of 400 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

SUK MIN SEO is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Fexuprazan group(P-CAB)

    Participants receive fexuprazan 40 mg once daily and lansoprazole placebo once daily.

    Drug: Fexuprazan 40mg

  • Active comparator
    Lansoprazole group(PPI)

    Participants receive lansoprazole 30 mg once daily and fexuprazan placebo once daily.

    Drug: Lansoprazole 30mg

Interventions

  • DrugFexuprazan 40mg

    Fexuprazan 40 mg orally once daily + Lansoprazole placebo Matching placebo orally once daily.

    Also known as: Fexuprazan, Fexuclue, P-CAB

  • DrugLansoprazole 30mg

    Lansoprazole 30 mg orally once daily. + Fexuprazan placebo Matching placebo orally once daily.

    Also known as: Lansoprazole, PPI

06

What researchers measure

Primary outcomes

  1. Time from randomization to first occurrence of a composite endpoint of upper gastrointestinal clinical events during the treatment period

    This composite outcome includes: 1. Confirmed upper gastrointestinal bleeding (confirmed by upper endoscopy or computed tomography); 2. Presumed upper gastrointestinal bleeding with a documented decrease in hemoglobin of ≥ 2 g/dL or decrease in hematocrit of ≥ 10% from baseline; 3. Symptomatic gastroduodenal ulcer confirmed by endoscopy or computed tomography without evidence of bleeding; 4. Persistent abdominal pain or dyspeptic symptoms with multiple erosive lesions confirmed by endoscopy 5. Gastroduodenal perforation or obstruction.

    Time frame: 6 months after randomization

Secondary outcomes

  1. Time from randomization to first occurrence of gastroesophageal reflux disease, as evidenced by symptomatic endoscopically-confirmed erosive esophagitis.

    Time frame: 6 months after randomization

  2. Time from randomization of first occurrence of low gastrointestinal bleeding (conformed by the endoscopy or CT scan)

    Time frame: 6 months after randomization

  3. Time from randomization to first occurrence of any GI bleeding

    Time frame: 6 months after randomization

  4. BARC bleeding (BARC type 0, 1, 2, 3, 5)

    Time frame: 6 months after randomization

  5. All-cause death (cardiovascular death, or non-cardiovascular death)

    Time frame: 6 months after randomization

  6. Rate of participants with myocardial infarction (target-vessel or non-target-vessel)

    Time frame: 6 months after randomization

  7. Rate of participants who underwent coronary revascularization (target-vessel or non-target-vessel)

    Time frame: 6 months after randomization

  8. Rate of participants with stent thrombosis

    Time frame: 6 months after randomization

  9. Rate of participants with stroke (ischemic, hemorrhagic, or transient ischemic attack)

    Time frame: 6 months after randomization

  10. Change in Dyspepsia-Related Health Assessed by the Severity of Dyspepsia Assessment (SODA) Questionnaire

    Dyspepsia-related health will be assessed using the Severity of Dyspepsia Assessment (SODA), a validated, disease-specific, self-administered patient-reported outcome measure (Rabeneck et al., J Clin Epidemiol 2001;54:755-765). The SODA comprises three subscales, each reported separately: (1) Pain Intensity (6 items; score range 2-47; higher scores indicate worse pain), (2) Non-Pain Symptoms (7 items; score range 7-35; higher scores indicate worse symptoms), and (3) Satisfaction with dyspepsia-related health (4 items; score range 2-23; higher scores indicate better satisfaction). The outcome is the mean change from baseline to 6 months for each subscale.

    Time frame: 6 months after randomization

07

Study locations

1 of 1 sites recruiting
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    Seoul, Eunpyeong-gu 03312, South Korea
    Recruiting
08

References and documents

Publications

  • Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM; DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155-66. doi: 10.1056/NEJMoa1409312. Epub 2014 Nov 16. PubMed 25399658 ↗
  • Niteen V. Deshpande; Bleeding on dual antiplatelet therapy: real-life challenges; European Heart Journal Supplements; 2018; 20 (Supplement B); B1-B9

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07479056
Lead sponsor
SUK MIN SEO
Collaborators
Daewoong Pharmaceutical Co. LTD.
Responsible party
SUK MIN SEO (Assisted Professor, Eunpyeong St. Mary's Hospital) — Sponsor-investigator
First posted
Mar 18, 2026
Start date
Oct 24, 2024
Primary completion
Apr 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 8, 2026

Study contacts

SUK MIN SEO, MD, PhD
Contact
ssm530@catholic.ac.kr
82+10-9090-8491
YUN JU KANG, CRC
Contact
yunju423@naver.com
82+10-7358-5252
Suk Seo, MD, PhD
principal investigator · The Catholic University of Korea Eunpyeong St. Mary's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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