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Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke
Sponsor: Asan Medical Center
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. 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)
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
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
984
Start Date
2026-10-15
Completion Date
2029-09-30
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Zastaprazan
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.
Placebo
Matching placebo for zastaprazan citrate 20 mg, administered orally once daily at a fixed dose, in addition to standard antiplatelet or anticoagulant therapy.
Locations (15)
Chungnam National University Hospital
Daejeon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Ajou University Hospital
Gyeonggi-do, South Korea
Hallym University Hospital
Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Uijeongbu Eulji Medical Center, Eulji University
Gyeonggi-do, South Korea
Catholic Kwandong University International St.Mary's Hospital
Incheon, South Korea
Jeju National University Hospital
Jeju City, South Korea
Jeonbuk National University Hospital
Jeonju, South Korea
Asan Medical Center
Seoul, South Korea
Ewha Womans University Seoul Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung Hee University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea