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Ischemic StrokePhase 3NCT07730840

Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke

A Phase 3 study testing Zastaprazan in people with Ischemic Stroke and Transient Ischemic Attack, run by Asan Medical Center at 15 sites in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if zastaprazan can help 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Ischemic Stroke, Transient Ischemic Attack
What is being tested?
Zastaprazan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
984 participants
Where
15 sitesSouth Korea
Study dates
15 Oct 2026to 30 Sep 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 19 years or older
  • Onset of transient ischemic attack (TIA) or ischemic stroke within 180 days prior to randomization
  • Currently initiating or receiving, at the time of randomization, one of the following treatments, with an expected treatment duration of at least 3 weeks:
  • 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
  • Provision of written informed consent by the participant (or legally authorized representative)

Who cannot join

  • Clinically significant peptic ulcer or gastrointestinal bleeding within 1 year prior to enrollment
  • Moderate to severe hepatic impairment (e.g., diagnosis of cirrhosis or confirmed esophageal/gastric varices)
  • Severe thrombocytopenia (platelet count <50,000/µL)
  • End-stage renal disease requiring dialysis, or unstable renal function precluding safe anticoagulant dose adjustment (eGFR <15 mL/min/1.73m²)
  • Known hypersensitivity to potassium-competitive acid blockers (P-CABs) or to the investigational product
  • History of major gastrointestinal surgery resulting in malabsorption, bowel obstruction, or inability to take oral medication
Show all 18Show fewer
  • History of osteoporotic fracture or fragility fracture
  • Diagnosis of a condition requiring long-term, high-dose systemic corticosteroid therapy
  • Diagnosis of a condition requiring long-term concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs)
  • Pregnant or breastfeeding women
  • Life expectancy of less than 6 months due to pre-existing comorbid conditions
  • Current participation in another interventional clinical trial that could affect the results of this study
  • Any condition that, in the investigator's judgment, precludes participation
  • 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
  • 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)
  • History of peptic ulcer complications, including bleeding, perforation, or stricture, regardless of timing
  • Active bleeding at the time of enrollment, history of a coagulation disorder, or hemodynamic instability at the time of enrollment
  • Known hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bum Joon Kim, MD, Ph.D. contact

+82-2- 3010-3981

bj.kim@amc.seoul.kr

15 sites in 1 country

South Korea15 sites
  • Chungnam National University Hospital

    Daejeon

    Jong Wook Shin, MD, PhD, 82-1599-7123, dr.shin@hanmail.net

  • Chonnam National University Hospital

    Gwangju

    Kang-Ho Choi, MD, PhD, 82-1899-9000, ckhchoikang@hanmail.net

  • Ajou University Hospital

    Gyeonggi-do

  • Hallym University Hospital

    Gyeonggi-do

    Mi Sun Oh, 82-1577-1801, iyyar0408@gmail.com

  • Seoul National University Bundang Hospital

    Gyeonggi-do

    Beom Joon Kim, MD, PhD, 82-1588-3369, kim.bj.stroke@gmail.com

  • Uijeongbu Eulji Medical Center, Eulji University

    Gyeonggi-do

    Dongwhane Lee, MD, PhD, 82-1899-0001, thepianist@naver.com

  • Catholic Kwandong University International St.Mary's Hospital

    Incheon

    Sang Joon An, MD, PhD, 82-1600-8291, neuroan@gmail.com

  • Jeju National University Hospital

    Jeju City

    Joong Goo Kim, MD, PhD, 82-64-717-1114, lilis1118@naver.com

  • Jeonbuk National University Hospital

    Jeonju

    Hyun Goo Kang, MD, PhD, 82-1577-7877, hgkang@jbnu.ac.kr

  • Asan Medical Center

    Seoul, 05505

    Bum Joon Kim, MD, PhD, +82-2-3010-3981, medicj80@hanmail.net

  • Ewha Womans University Seoul Hospital

    Seoul

    Tae-Jin Song, MD, PhD, 82-1522-7000, knstar@hanmail.net

  • Korea University Guro Hospital

    Seoul

    Chi Kyung Kim, MD, PhD, 82-1577-9966, ckkim7@gmail.com

  • Kyung Hee University Hospital

    Seoul

    Hogeol Woo, MD, PhD, 82-2-958-8114, nr85plasma@gmail.com

  • Samsung Medical Center

    Seoul

    Hyung Jun Kim, MD, PhD, 82-1599-3114, khhhj7@naver.com

  • Yonsei University Health System, Severance Hospital

    Seoul

    JoonNyung Heo, MD, PhD, 82-1599-1004, JNHEO@yuhs.ac

Other trials in South Korea

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy of Zastaprazan in PrEventing Upper Gastrointestinal Bleeding in Patients With Transient Ischemic Attack or Ischemic Stroke Receiving Antiplatelet or Anticoagulant Therapy: ZEUS Trial

The goal of this clinical trial is to learn if zastaprazan can help 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. The main question it aims to answer is:

  • Does zastaprazan reduce the risk of upper gastrointestinal bleeding compared to placebo in these patients?
Read more

Researchers will compare zastaprazan to a placebo (a look-alike tablet that contains no drug) to see if zastaprazan works to prevent upper gastrointestinal bleeding.

Participants will:

  • Take zastaprazan (20 mg) or a placebo once daily for the duration of the study, in addition to their prescribed antiplatelet or anticoagulant medication
  • Visit the study site regularly for safety monitoring, including vital signs, physical exams, and laboratory tests
  • Be monitored for any signs of gastrointestinal bleeding or other adverse events for up to approximately 3 years (including screening, treatment, and follow-up periods)
Being tested
Zastaprazan, Placebo
Medical subject headings
Ischemic Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZastaprazanDrug

    Zastaprazan citrate 20 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily at a fixed dose, in addition to standard antiplatelet or anticoagulant therapy.

  • PlaceboDrug

    Matching placebo for zastaprazan citrate 20 mg, administered orally once daily at a fixed dose, in addition to standard antiplatelet or anticoagulant therapy.

Study groups in NCT07730840
Study groupRoleWhat they receive
ZastaprazanExperimentalParticipants will receive zastaprazan citrate 20 mg, administered orally once daily (QD) at a fixed dose, in addition to their prescribed antiplatelet therapy (dual antiplatelet therapy) or oral anticoagulant therapy (NOAC or warfarin).
Receives: Drug: Zastaprazan
PlaceboPlacebo comparatorParticipants will receive a matching placebo for zastaprazan 20 mg, administered orally once daily (QD) at a fixed dose, in addition to their prescribed antiplatelet therapy (dual antiplatelet therapy) or oral anticoagulant therapy (NOAC or warfarin).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to First Composite Clinical Event of Upper Gastrointestinal Bleeding as Adjudicated by the Clinical Event Committee (CEC)

    Time from randomization to the first occurrence of a composite clinical event of upper gastrointestinal (GI) bleeding, as adjudicated by the Clinical Event Committee (CEC). The composite event includes: (1) upper GI bleeding confirmed by endoscopy or imaging, with hematemesis and/or melena; (2) upper GI bleeding of unclear origin, judged by the investigator to originate from the upper GI tract; (3) occult GI bleeding, defined as a decrease in hemoglobin ≥2 g/dL or hematocrit ≥10%; (4) symptomatic uncomplicated gastroduodenal ulcer, confirmed by endoscopy or imaging with persistent pain (≥3 days) and no evidence of bleeding; (5) symptomatic gastroduodenal erosive lesions, with persistent pain (≥3 days) and ≥5 gastroduodenal erosions confirmed by endoscopy, excluding mucosal bleeding; (6) upper GI obstruction; and (7) upper GI perforation.

    Measured: From randomization up to end of study (up to approximately 3 years, including a 24-month enrollment period and 12-month follow-up)

Secondary outcomes (15)
  1. Time to First Composite Clinical Event of Upper Gastrointestinal Bleeding as Judged by the Investigator

    Measured: From randomization up to end of study (up to approximately 3 years)

  2. Time to First Upper Gastrointestinal Bleeding Event Confirmed by Endoscopy or Imaging, as Adjudicated by the Clinical Event Committee (CEC)

    Measured: From randomization up to end of study (up to approximately 3 years)

  3. Time to First Upper Gastrointestinal Bleeding Event of Unclear Origin, as Adjudicated by the Clinical Event Committee (CEC)

    Measured: From randomization up to end of study (up to approximately 3 years)

  4. Time to First Occult Gastrointestinal Bleeding Event, as Adjudicated by the Clinical Event Committee (CEC)

    Measured: From randomization up to end of study (up to approximately 3 years)

  5. Time to First Symptomatic Uncomplicated Gastroduodenal Ulcer Event, as Adjudicated by the Clinical Event Committee (CEC)

    Measured: From randomization up to end of study (up to approximately 3 years)

  6. Time to First Symptomatic Gastrointestinal Erosive Lesion Event, as Adjudicated by the Clinical Event Committee (CEC)

    Measured: From randomization up to end of study (up to approximately 3 years)

  7. Time to First Upper Gastrointestinal Obstruction Event, as Adjudicated by the Clinical Event Committee (CEC)

    Measured: From randomization up to end of study (up to approximately 3 years)

  8. Time to First Upper Gastrointestinal Perforation Event, as Adjudicated by the Clinical Event Committee (CEC)

    Measured: From randomization up to end of study (up to approximately 3 years)

  9. Time to First All Gastrointestinal Bleeding Event (Upper and Lower), Including International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding or clinically relevant non-major bleeding (CRNMB)

    Measured: From randomization up to end of study (up to approximately 3 years)

  10. Time to First Lower Gastrointestinal Bleeding Event

    Measured: From randomization up to end of study (up to approximately 3 years)

  11. Time to First Non-Gastrointestinal ISTH Major Bleeding or CRNMB Event

    Measured: From randomization up to end of study (up to approximately 3 years)

  12. Time to First Clinically Significant Non-Bleeding Upper Gastrointestinal Event

    Measured: From randomization up to end of study (up to approximately 3 years)

  13. Time to First Hemoglobin-Related Event

    Measured: From randomization up to end of study (up to approximately 3 years)

  14. Time to First Cerebrovascular or Cardiovascular Event

    Time from randomization to the first occurrence of a cerebrovascular or cardiovascular event, including ischemic stroke, transient ischemic attack, systemic embolism, myocardial infarction, or vascular death.

    Measured: From randomization up to end of study (up to approximately 3 years)

  15. All-Cause Mortality

    Measured: From randomization up to end of study (up to approximately 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
984 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07730840
Sponsor's protocol ID
ZEUS
Status last verified
Oct 2026
First submitted
23 Jul 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zastaprazan in people with Ischemic Stroke and Transient Ischemic Attack, run by Asan Medical Center at 15 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bum Joon Kim, MD, Ph.D. (+82-2- 3010-3981, bj.kim@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Composite Clinical Event of Upper Gastrointestinal Bleeding as Adjudicated by the Clinical Event Committee (CEC) (time frame: From randomization up to end of study (up to approximately 3 years, including a 24-month enrollment period and 12-month follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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