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Could a stomach acid blocker shield stroke patients from bleeding?

NCT ID NCT07687706

Disease control Sponsor: Hanyang University Guri Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether tegoprazan, a stomach acid blocker, can prevent gastrointestinal complications like bleeding and ulcers in people who have had an ischemic stroke and are taking antiplatelet drugs (blood thinners). About 1,500 adults in South Korea will receive either tegoprazan or a placebo daily for 180 days, and their stomachs will be examined with a camera at the end. The goal is to provide the first solid evidence on whether routine stomach protection is beneficial in stroke care.

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 establish a standard way to protect the stomach in stroke patients on blood thinners, reducing serious bleeding complications.
What could go wrong
This is a single-country trial, and results may not apply to all populations. The drug may not reduce complications enough to justify routine use, and side effects are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,524 people

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

Started

Jan 2026

Expected to finish

Dec 2027

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. Age 19 years or older. 2. Hospitalization for acute ischemic stroke or transient ischemic attack, with antiplatelet therapy initiated for the first time, expected to continue for at least 6 months at the treating physician's discretion per relevant stroke guidelines, and within 4 weeks of the first antiplatelet dose at the time of randomization. 3. Written informed consent provided by the participant or a legally authorized representative. 4. Ability and willingness to understand the study procedures described in the consent form and to comply with the study protocol. Exclusion Criteria: 1. History of peptic ulcer disease diagnosis or gastrointestinal bleeding within the past year. At screening, the history and findings of any EGD performed within the preceding 2 years were obtained by participant interview. 2. Need for concomitant anticoagulant therapy (transient anticoagulation such as argatroban during the index admission is permitted, with randomization after it is stopped) 3. Anticipated difficulty in undergoing gastrointestinal endoscopy during the study period. 4. Use of a P-CAB, PPI, or H2-receptor antagonist within 1 week before randomization, or an active indication for these agents, a mucosal protectant, or an antacid at enrollment. Temporary use of these agents during acute care in the index admission, since discontinued and without a current indication, is not exclusionary. 5. Hypersensitivity or contraindication to a P-CAB or to benzimidazoles. 6. AST, ALT, ALP, or γ-GT ≥5 times the upper limit of normal (ULN), or total bilirubin ≥3 times the ULN at screening. 7. Participation within the past 12 months in any of the following: (1) a clinical study that may affect the efficacy or safety assessments of the present study; (2) a study involving an investigational product or procedure not administered under standard-of-care guidelines; (3) a study that may pose additional risk to the participant. (Participation in other clinical studies is otherwise permitted.) 8. Current use of, or use within five half-lives of, a contraindicated interacting drug (atazanavir, nelfinavir, rilpivirine, and preparations containing these components). 9. Any other condition deemed by the investigators to render the patient unsuitable for study participation, including but not limited to:

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Conditions

The condition(s) this trial relates to.

cerebrovascular disorder Gastrointestinal Hemorrhage ischemic stroke transient ischemic attack duodenal ulcer prevention target gastric ulcer prevention target peptic esophagitis prevention target

As listed by the trial registrant

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

Cerebrovascular disease Gastrointestinal bleeding Gastrointestinal complication Ischemic stroke Ischemic stroke, acute Transient ischemic attack (TIA)

How to take part

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

  1. The places running it

    24 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

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, South Korea

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, North Chungcheong, South Korea

  • Dong-A University Hospital

    RECRUITING

    Busan, South Korea

  • Ewha Womans University Seoul Hospital

    RECRUITING

    Seoul, South Korea

  • Gangnam Severance Hospital

    RECRUITING

    Seoul, South Korea

  • Hallym University Chuncheon Sacred Heart Hospital

    RECRUITING

    Chuncheon, Gangwon-do, South Korea

  • Hallym University Sacred Heart Hospital

    RECRUITING

    Anyang-si, Gyeonggi-do, South Korea

  • Hanyang University Guri Hospital

    RECRUITING

    Guri-si, South Korea

  • Hanyang University Hospital

    RECRUITING

    Seoul, South Korea

  • Jeonbuk National University Hospital

    RECRUITING

    Jeonju, Jeollabuk-do, South Korea

  • Kangdong Sacred Heart Hospital

    RECRUITING

    Seoul, South Korea

  • Kangwon National University Hospital

    RECRUITING

    Chuncheon, Gangwon-do, South Korea

  • Keimyung University Dongsan Hospital

    RECRUITING

    Daegu, Daegu, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, South Korea

  • Korea University Ansan Hospital

    RECRUITING

    Seoul, South Korea

  • Kyung Hee University Hospital

    RECRUITING

    Seoul, South Korea

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Daegu, South Korea

  • Pusan National University Hospital

    RECRUITING

    Busan, Busan, South Korea

  • Seoul Metropolitan Government-Seoul National University Boramae Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Ulsan University Hospital

    RECRUITING

    Ulsan, South Korea

  • Wonkwang University Hospital

    RECRUITING

    Iksan, Jeollabuk-do, South Korea

  • Yeungnam University Medical Center

    RECRUITING

    Daegu, South Korea

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