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New stomach drug could shield heart patients from bleeding

NCT ID NCT04416581

Disease control Sponsor: Duk-Woo Park, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study compares two stomach-acid-lowering drugs—tegoprazan and rabeprazole—in about 3,300 heart disease patients who take blood thinners and are at high risk for stomach bleeding. The goal is to see if tegoprazan works as well as rabeprazole at preventing serious gut problems like bleeding or ulcers over 12 months. Participants will be randomly assigned to take one of the two drugs daily.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tegoprazan
What this could lead to
If successful, this could offer a new option to protect the stomach and gut from bleeding in people with heart disease who must take blood thinners.
What could go wrong
This is a non-inferiority trial, meaning it only aims to show tegoprazan is not worse than the standard drug. It may not prove it is better, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 3,320 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

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

19 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients 19 years of age or older with known cardiac and vascular disease who are receiving chronic use of antithrombotic drugs (either antiplatelets, oral anticoagulant (OAC), and its combinations). Specific clinical conditions that may confer a need for long-term antithrombotic therapy may include documented coronary artery disease (stable or unstable angina, acute coronary syndrome, a history of myocardial infarction, or any coronary revascularization), documented cerebrovascular disease (stroke or transient ischemic attack), known peripheral arterial disease or a history of peripheral arterial revascularization, atrial fibrillation, or valvular heart disease requiring interventions (transcatheter aortic valve replacement or transcatheter mitral-valve repair). Concomitant use of a proton pump inhibitor is strongly recommended in patients receiving aspirin monotherapy, DAPT (dual antiplatelet therapy; aspirin plus any P2Y12 inhibitors), DAT (dual antithrombotic therapy; antiplatelet drug plus OAC), TAT (triple antithrombotic therapy; DAPT plus OAC), or OAC monotherapy (warfarin or direct oral anticoagulants) who are at high risk of GI bleeding in order to reduce the risk of gastric bleed or GI events. Based on clinical guidelines, the use of P2Y12 inhibitor monotherapy (i.e. clopidogrel, ticagrelor, or prasugrel) is not considered in trial enrollment. 2. On the basis of clinical guidelines and expert consensus documents, we defined a study population with an increased risk of gastrointestinal bleeding if they had a least 1 or more criteria of the following characteristics. Eligible patients for randomization must meet at least 1 characteristic of these criteria: \*Definition of patients who are at high risk of gastrointestinal bleeding 1. Age ≥65 years 2. Concomitant use of OAC and any antiplatelet therapy (mono or DAPT) (i.e., DAT or TAT) 3. Long-term use of oral NSAIDs (non-steroidal anti-inflammatory drugs) or steroids or high-dose NSAID therapy even during a relatively short-term period. 4. History of prior GI bleeding events at any time 5. History of a previously complicated ulcer 6. History of peptic ulcer disease or a previously uncomplicated ulcer 7. Documented Helicobacter pylori infection 3. Patients who voluntarily participated in the written agreement Exclusion Criteria: 1. Active bleeding at the time of inclusion or a history of hereditary or acquired hemostatic disorder 2. Any clinical contraindication to using of antithrombotic therapies (antiplatelet agents or OAC) 3. Concurrent use of PPI or P-CAB within 4 weeks before randomization 4. Hemodynamically unstable conditions at the time of inclusion: cardiogenic shock at the time of randomization, refractory ventricular arrhythmias, or congestive heart failure (New York Heart Association class IV). 5. Baseline severe anemia (Hgb \<8 g/dl at baseline) or transfusion within 4 weeks before randomization 6. Baseline severe thrombocytopenia (platelet count \<50,000/mm3) 7. Renal failure dependent on dialysis or severe renal insufficiency (creatinine clearance \<15 ml/min) 8. Severe chronic liver disease (defined as variceal haemorrhage, ascites, hepatic encephalopathy, or jaundice) 9. Hypersensitivity or contraindication to PPI, P-CAB, any of the product components, or substituted benzimidazoles 10. Use of clarithromycin and hypersensitivity to macrolide antibiotics for Helicobacter pylori eradication 11. Concomitant use of clarithromycin with terfenadine, cisapride, astemizole, or pimozide for Helicobacter pylori eradication 12. Systemic treatment with strong CYP 3A4 and p-glycoprotein (P-GP) inhibitors (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus \[HIV\]-protease inhibitors, such as ritonavir) 13. Patients who take atazanavir, nelfinavir, or rilpivirine-containing products (see Drug-Drug interaction section) 14. Clinically significant laboratory abnormality at screening (estimated glomerular filtration rate (eGFR) \<15 mL/min or elevated liver enzyme \[AST, ALT, ALP, total bilirubin\] \> 3 times upper normal limit \[UNL\] or any other condition that, in the opinion of the Investigator, precludes participation in the study 15. Any known or suspected malignancy 16. Patients with non-cardiac co-morbidities with a life expectancy of less than 12 months 17. Patients with active treatment for H-pylori infection 18. Women who are pregnant or breastfeeding or female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening 19. Participation in another clinical study within 12 months. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion; 1. Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial 2. Screening failed before any interventional factor is involved 3. Participated in academic trials like strategic or medical device comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome atrial fibrillation cerebrovascular disorder coronary artery disorder Gastrointestinal Hemorrhage heart valve disorder myocardial infarction peptic ulcer disease peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute coronary syndrome Coronary artery disease Myocardial infarction Percutaneous coronary intervention

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Ajou University Hospital

    RECRUITING

    Suwon, South Korea

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Bucheon Sejong Hospital

    RECRUITING

    Bucheon-si, South Korea

  • Bundang CHA Hospital

    RECRUITING

    Seongnam, South Korea

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, South Korea

  • Chung-Ang University Hospital

    RECRUITING

    Seoul, South Korea

  • Chungbuk National University Hospital

    RECRUITING

    Cheonju, South Korea

  • Chungnam National University Hospital

    RECRUITING

    Daejeon, South Korea

  • Chungnam National University Sejong Hospital

    RECRUITING

    Sejong, South Korea

  • Dankook University Hospital

    WITHDRAWN

    Cheonan, South Korea

  • Dong-A Medical Center

    RECRUITING

    Pusan, South Korea

  • Ewha Womans University Medical Center

    WITHDRAWN

    Seoul, South Korea

  • Gangneung Asan Hospital

    RECRUITING

    Gangneung, South Korea

  • Gangwon National Univ. Hospital

    NOT_YET_RECRUITING

    Chuncheon, South Korea

  • Gyeongsang National University Changwon Hospital

    WITHDRAWN

    Changwon, South Korea

  • Hallym University Chuncheon Sacred Heart Hospital

    NOT_YET_RECRUITING

    Chuncheon, South Korea

  • Hallym University Dongtan Sacred Heart Hospital

    RECRUITING

    Hwaseong-si, South Korea

  • Hallym University Kangnam Sacred Heart Hospital

    RECRUITING

    Seoul, South Korea

  • Hallym University Sacred Heart Hospital

    RECRUITING

    Anyang, South Korea

  • Hanyang University Guri Hospital

    RECRUITING

    Guri-si, South Korea

  • Hanyang University Seoul Hospital

    RECRUITING

    Seoul, South Korea

  • Inje University Ilsan Paik Hospital

    RECRUITING

    Ilsan, South Korea

  • Inje University Pusan Paik Hospital

    RECRUITING

    Pusan, South Korea

  • Jeonbuk National University Hospital

    WITHDRAWN

    Jeonju, South Korea

  • Kangbuk Samsung Hospital

    RECRUITING

    Seoul, South Korea

  • Keimyung University Dongsan Medical Center

    RECRUITING

    Daegu, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, South Korea

  • Kosin University Gospel Hospital

    RECRUITING

    Busan, South Korea

  • Kwangju Christian Hospital

    WITHDRAWN

    Kwangju, South Korea

  • Kyung Hee University Hospital at Gangdong

    RECRUITING

    Seoul, South Korea

  • Kyung Hee University Medical Center

    RECRUITING

    Seoul, South Korea

  • Pusan National University Hospital

    RECRUITING

    Pusan, South Korea

  • Pusan National University Yangsan Hospital

    RECRUITING

    Yangsan, South Korea

  • SNU Boramae Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Seoul university Bundang hospital

    RECRUITING

    Seongnam-si, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, South Korea

  • Sungkyunkwan University Samsung Changwon Hospital

    WITHDRAWN

    Changwon, South Korea

  • The Catholic Univ. of Korea Eunpyeong St. Mary's hospital

    RECRUITING

    Seoul, South Korea

  • The Catholic Univ. of Korea Seoul St. Mary's hospital

    RECRUITING

    Seoul, South Korea

  • The Catholic University of Korea, ST. Vincent's Hospital

    RECRUITING

    Suwon, South Korea

  • Ulsan University Hospital

    RECRUITING

    Ulsan, South Korea

  • Yeungnam University Medical Center

    WITHDRAWN

    Daegu, South Korea

  • Yonsei University Yongin Severance Hospital

    RECRUITING

    Yongin-si, South Korea

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