Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke

Prior treatment

• Clinically significant peptic ulcer or gastrointestinal bleeding within 1 year prior to enrollment
• Diagnosis of a condition requiring long-term concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs)
• 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)

Other illness

• Moderate to severe hepatic impairment (e.g., diagnosis of cirrhosis or confirmed esophageal/gastric varices)
• 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
• Life expectancy of less than 6 months due to pre-existing comorbid conditions
• Any condition that, in the investigator's judgment, precludes participation
• 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

Lab values

• 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
• Known hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

Other

• Pregnant or breastfeeding women
• Current participation in another interventional clinical trial that could affect the results of this study
• 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

• 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)