About this 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?
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)
Eligibility criteria
Qualifiers
Adults aged 19 years or older
Onset of transient ischemic attack (TIA) or ischemic stroke within 180 days prior to randomization
Provision of written informed consent by the participant (or legally authorized representative)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Zastaprazan
- Placebo
Treatment groups
Sponsors and collaborators
Asan Medical Center
Lead sponsor
Jeil Pharmaceutical Co., Ltd.
Collaborator