drugset / Trial / NCT07730840

Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke

NCT07730840 ↗

Phase 3 Not yet recruiting 984 enrolled Asan Medical Center Jeil Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupQuadruple-blindTreatment

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)

Timeline

Start
2026-10-15
Primary completion
2029-09-30
Completion
2029-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Zastaprazan Unknown 20 mg Oral