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A daily pill that may shield stroke patients from stomach bleeding while on blood thinners

NCT ID NCT07730840

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether zastaprazan, a stomach-acid-blocking drug, can prevent upper gastrointestinal bleeding in adults who have recently had a transient ischemic attack (TIA) or ischemic stroke and are taking antiplatelet or anticoagulant medications. Participants take either zastaprazan or a placebo daily alongside their prescribed blood thinner. Researchers monitor for signs of bleeding or other side effects over up to three years.

What this could mean

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

Active substance
zastaprazan, a potassium-competitive acid blocker (P-CAB) taken as a daily pill
What this could lead to
If it works, zastaprazan could become a standard preventive treatment to protect stroke and TIA patients from dangerous stomach bleeding while on blood thinners.
What could go wrong
This is a phase 3 trial, but the drug is still experimental. It may not reduce bleeding risk more than placebo, and any new drug carries unknown side effects.

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 984 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

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. Adults aged 19 years or older 2. Onset of transient ischemic attack (TIA) or ischemic stroke within 180 days prior to randomization 3. Currently initiating or receiving, at the time of randomization, one of the following treatments, with an expected treatment duration of at least 3 weeks: A. Dual antiplatelet therapy (DAPT) - aspirin in combination with one of the following: clopidogrel, ticagrelor, prasugrel, or cilostazol B. Oral anticoagulant therapy - a NOAC (apixaban, rivaroxaban, dabigatran, or edoxaban) or warfarin 4. Provision of written informed consent by the participant (or legally authorized representative) Exclusion Criteria: 1. Clinically significant peptic ulcer or gastrointestinal bleeding within 1 year prior to enrollment 2. Moderate to severe hepatic impairment (e.g., diagnosis of cirrhosis or confirmed esophageal/gastric varices) 3. Severe thrombocytopenia (platelet count \<50,000/µL) 4. End-stage renal disease requiring dialysis, or unstable renal function precluding safe anticoagulant dose adjustment (eGFR \<15 mL/min/1.73m²) 5. Known hypersensitivity to potassium-competitive acid blockers (P-CABs) or to the investigational product 6. History of major gastrointestinal surgery resulting in malabsorption, bowel obstruction, or inability to take oral medication 7. History of osteoporotic fracture or fragility fracture 8. Diagnosis of a condition requiring long-term, high-dose systemic corticosteroid therapy 9. Diagnosis of a condition requiring long-term concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) 10. Pregnant or breastfeeding women 11. Life expectancy of less than 6 months due to pre-existing comorbid conditions 12. Current participation in another interventional clinical trial that could affect the results of this study 13. Any condition that, in the investigator's judgment, precludes participation 14. Participant or partner of childbearing/reproductive potential who does not agree to use a medically acceptable method of contraception, or to abstain from sexual activity with risk of pregnancy, during the study period 15. Currently receiving, or having received within 5 half-lives prior to randomization, a prohibited concomitant medication expected to interact with the investigational product (products containing atazanavir, nelfinavir, or rilpivirine) 16. History of peptic ulcer complications, including bleeding, perforation, or stricture, regardless of timing 17. Active bleeding at the time of enrollment, history of a coagulation disorder, or hemodynamic instability at the time of enrollment 18. Known hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Asan Medical Center

    Seoul, 05505, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.