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New combo therapy aims to cut stomach bleeding risk in heart patients

NCT ID NCT07497893

Disease control Sponsor: Ewha Womans University Mokdong Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test whether adding fexuprazan, a stomach acid reducer, to standard blood thinners can prevent upper gastrointestinal bleeding in people with atrial fibrillation. About 1,000 high-risk participants will be randomly assigned to receive either the combination therapy or blood thinners alone. The main goal is to see if fexuprazan reduces the chance of serious stomach bleeding over one year.

What this could mean

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

Active substance
fexuprazan
What this could lead to
If it works, this could show that adding fexuprazan to blood thinners reduces the risk of serious stomach bleeding in people with atrial fibrillation.
What could go wrong
This trial hasn't started yet, and it's testing a new use for fexuprazan. The expected benefit is based on assumptions, and the results may not show a clear advantage over current care.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,000 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Nov 2032

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

18 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: * Age ≥18 years * Documented non-valvular atrial fibrillation * Receiving or initiating therapy with a non-vitamin K antagonist oral anticoagulant (NOAC) at guideline-recommended dosing * At least one high-risk factor for upper gastrointestinal bleeding, including: * Age ≥75 years * Chronic kidney disease (eGFR \<60 mL/min/1.73 m²) * Concomitant antiplatelet therapy * Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids * Prior peptic ulcer disease or upper gastrointestinal bleeding * HAS-BLED score ≥3 Exclusion Criteria: * Active gastrointestinal bleeding at the time of screening * Requirement for mandatory long-term proton pump inhibitor (PPI) therapy that cannot be discontinued * Severe hepatic dysfunction * Life expectancy \<1 year * Known hypersensitivity or contraindication to fexuprazan * Participation in another interventional clinical trial that may interfere with study outcomes

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Drug-Related Side Effects and Adverse Reactions Gastrointestinal Hemorrhage

As listed by the trial registrant

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

Atrial fibrillation (AF) Drug-related side effects and adverse reactions Gastrointestinal hemorrhage (clinically important, upper) Upper gastrointestinal bleeding (UGIB)

How to take part

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

  1. The places running it

    1 site. 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

  • Ewha Womans University Mokdong Hospital

    Seoul, 1071, South Korea

More trials for these conditions

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