Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke

Conditions

• Ischemic Stroke
• Transient Ischemic Attack

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zastaprazan — DRUG
  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 — DRUG
  Matching placebo for zastaprazan citrate 20 mg, administered orally once daily at a fixed dose, in addition to standard antiplatelet or anticoagulant therapy.

Study Details

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)

Key Dates

First listed

Jul 28, 2026

Start date

Oct 15, 2026

Status verified

Jul 2026

Primary completion

Sep 30, 2029

Completion

Sep 30, 2029

Study Design

Enrollment

984 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Zastaprazan
  Participants will receive zastaprazan citrate 20 mg, administered orally once daily (QD) at a fixed dose, in addition to their prescribed antiplatelet therapy (dual antiplatelet therapy) or oral anticoagulant therapy (NOAC or warfarin).
• Placebo Comparator: Placebo
  Participants will receive a matching placebo for zastaprazan 20 mg, administered orally once daily (QD) at a fixed dose, in addition to their prescribed antiplatelet therapy (dual antiplatelet therapy) or oral anticoagulant therapy (NOAC or warfarin).

Primary Outcome Measure

Time to First Composite Clinical Event of Upper Gastrointestinal Bleeding as Adjudicated by the Clinical Event Committee (CEC) [ Time Frame: From randomization up to end of study (up to approximately 3 years, including a 24-month enrollment period and 12-month follow-up) ]

Central Contacts

• Bum Joon Kim, MD, Ph.D.
  +82-2- 3010-3981
  [email protected]

Find similar trials

Related Studies

• Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
  Recruiting · Cedars-Sinai Medical Center · Los Angeles, California
• Stroke Recovery Initiative - Registry for Stroke Research Studies
  Recruiting · University of California, San Francisco · San Francisco, California
• Verapamil for Neuroprotection in Stroke
  PHASE1/PHASE2 · Recruiting · Global Neurosciences Institute · Atlantic City, New Jersey
• The Recovery in Stroke Using PAP Study
  Recruiting · Yale University · New Haven, Connecticut