None listed
Conditions
Interventions
Drug : Participants will be randomized in a 1:1 ratio to either the experimental arm (zastaprazan citrate 20 mg) or the placebo control arm.
1) Dose and Duration
Experimental arm: Zastaprazan citrate
the investigational product may be taken without regard to meals.
3) Frequency of Administration
One tablet, once daily (QD), administered at approximately the same time each day whenever possible.
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to First Composite Clinical Event of Upper Gastrointestinal Bleeding as Judged by the Investigator;Time to First Upper Gastrointestinal Bleeding Event Confirmed by Endoscopy or Imaging, as Adjudicated by the Clinical Event Committee (CEC); Time to First Upper Gastrointestinal Bleeding Event of Unclear Origin, as Adjudicated by the Clinical Event Committee (CEC); Time to First Occult Gastrointestinal Bleeding Event, as Adjudicated by the Clinical Event Committee (CEC); Time to First Symptomatic Uncomplicated Gastroduodenal Ulcer Event, as Adjudicated by the Clinical Event Committee (CEC);Time to First Symptomatic Gastrointestinal Erosive Lesion Event, as Adjudicated by the Clinical Event Committee (CEC);Time to First Upper Gastrointestinal Obstruction Event, as Adjudicated by the Clinical Event Committee (CEC);Time to First Upper Gastrointestinal Perforation Event, as Adjudicated by the Clinical Event Committee (CEC);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);Time to First Lower Gastrointestinal Bleeding Event;Time to First Non-Gastrointestinal ISTH Major Bleeding or CRNMB Event; Time to First Clinically Significant Non-Bleeding Upper Gastrointestinal Event;Time to First Hemoglobin-Related Event;Time to First Cerebrovascular or Cardiovascular Event;All-Cause Mortality | — |
Countries
Korea, Republic of
Contacts
Public ContactYunJung Kim
Asan Medical Center
Outcome results
None listed