Acute Coronary Syndromes (ACS)SAINT-FEXUDAPTNCT07479056
Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy
A study testing Fexuprazan 40mg and Lansoprazole 30mg in people with Acute Coronary Syndromes (ACS) and Coronary Artery Disease (CAD), run by SUK MIN SEO at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD)
- What is being tested?
- Fexuprazan 40mg and Lansoprazole 30mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Oct 2024to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All four conditions below must be met.
- 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.
- 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.)
Who cannot join
- 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
Show all 16Show fewer
- 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.
- Active liver disease or impaired liver function (AST or ALT greater than three times the upper limit of normal).
- Advanced renal dysfunction: eGFR less than 30 mLmin/1.73m2 or patients receiving dialysis
- Patients taking drugs contraindicated for this clinical trial drug (e.g., patients taking atazanavir, nelfinavir, or rilpivirine-containing preparations)
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Concurrently taking CYP 3A4 and p-glycoprotein (P-GP) inhibitors.
- Dementia or individuals unable to understand the trial procedures or comply with the trial requirements
- Pregnant or breastfeeding women, or women planning to become pregnant
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, 03312
SUK MIN SEO, Assisted Professor, 82+10-9090-8491, ssm530@catholic.ac.kr
YUN JU KANG, 82+10-7358-5252, yunju423@naver.com
About this study
Official title: Randomized Active-Controlled Trial Evaluating Fexuprazan for Prevention Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy After Coronary Intervention-Fexuprazan for Patients With Dual Antiplatelet Therapy Trial
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 200 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 200 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
- Being tested
- Fexuprazan 40mg, Lansoprazole 30mg
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fexuprazan 40mgDrug
Also called Fexuprazan, Fexuclue, P-CAB
Fexuprazan 40 mg orally once daily + Lansoprazole placebo Matching placebo orally once daily.
Lansoprazole 30mgDrug
Also called Lansoprazole, PPI
Lansoprazole 30 mg orally once daily. + Fexuprazan placebo Matching placebo orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Fexuprazan group(P-CAB) | Experimental | Participants receive fexuprazan 40 mg once daily and lansoprazole placebo once daily. Receives: Drug: Fexuprazan 40mg |
| Lansoprazole group(PPI) | Active comparator | Participants receive lansoprazole 30 mg once daily and fexuprazan placebo once daily. Receives: Drug: Lansoprazole 30mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomization to first occurrence of a composite endpoint of upper gastrointestinal clinical events during the treatment period
This composite outcome includes:
- Confirmed upper gastrointestinal bleeding (confirmed by upper endoscopy or computed tomography);
- Presumed upper gastrointestinal bleeding with a documented decrease in hemoglobin of ≥ 2 g/dL or decrease in hematocrit of ≥ 10% from baseline;
- Symptomatic gastroduodenal ulcer confirmed by endoscopy or computed tomography without evidence of bleeding;
- Persistent abdominal pain or dyspeptic symptoms with multiple erosive lesions confirmed by endoscopy
- Gastroduodenal perforation or obstruction.
Measured: 6 months after randomization
Secondary outcomes (10)
Time from randomization to first occurrence of gastroesophageal reflux disease, as evidenced by symptomatic endoscopically-confirmed erosive esophagitis.
Measured: 6 months after randomization
Time from randomization of first occurrence of low gastrointestinal bleeding (conformed by the endoscopy or CT scan)
Measured: 6 months after randomization
Time from randomization to first occurrence of any GI bleeding
Measured: 6 months after randomization
BARC bleeding (BARC type 0, 1, 2, 3, 5)
Measured: 6 months after randomization
All-cause death (cardiovascular death, or non-cardiovascular death)
Measured: 6 months after randomization
Rate of participants with myocardial infarction (target-vessel or non-target-vessel)
Measured: 6 months after randomization
Rate of participants who underwent coronary revascularization (target-vessel or non-target-vessel)
Measured: 6 months after randomization
Rate of participants with stent thrombosis
Measured: 6 months after randomization
Rate of participants with stroke (ischemic, hemorrhagic, or transient ischemic attack)
Measured: 6 months after randomization
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.
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start24 Oct 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SUK MIN SEO
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Sponsor-investigator, SUK MIN SEO, Eunpyeong St. Mary's Hospital
- Investigators
- Suk Seo, MD, PhD, Principal investigator, The Catholic University of Korea Eunpyeong St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479056
- Sponsor's protocol ID
- PC24MIST0009
- Other IDs
- KCT0009504
- Acronym
- SAINT-FEXUDAPT
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 25399658Niteen V. Deshpande; Bleeding on dual antiplatelet therapy: real-life challenges; European Heart Journal Supplements; 2018; 20 (Supplement B); B1-B9