Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Ischemic Stroke, Transient Ischemic Attack

In brief

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? 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)

Key facts

Study ID

NCT07730840

Run by

Asan Medical Center

People needed

984

Starts

2026-10-15

Expected to finish

2029-09-30

Last updated by the study team

2026-07-28

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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
• Provision of written informed consent by the participant (or legally authorized representative)

You may not qualify if…

• 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
• 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

Where it is running

• Asan Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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