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Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke

NCT07730840 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 984

Last updated 2026-07-28

No results posted yet for this study

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)

Conditions

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.

Sponsors & Collaborators

  • Jeil Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Bum Joon Kim, Ph.D. · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07730840 on ClinicalTrials.gov