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NOT YET RECRUITING
NCT07730840
PHASE3

Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke

Sponsor: Asan Medical Center

View on ClinicalTrials.gov

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

2026-07-28

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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 (1)

Asan Medical Center

Seoul, South Korea