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Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke

ConditionsIschemic StrokeTransient Ischemic Attack
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorAsan Medical Center

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

984 Participants
are divided into 2 treatment groups
Group A: ZastaprazanExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to First Composite Clinical Event of Upper Gastrointestinal Bleeding as Adjudicated by the Clinical Event Committee (CEC)

Time from randomization to the first occurrence of a composite clinical event of upper gastrointestinal (GI) bleeding, as adjudicated by the Clinical Event Committee (CEC). The composite event includes: (1) upper GI bleeding confirmed by endoscopy or imaging, with hematemesis and/or melena; (2) upper GI bleeding of unclear origin, judged by the investigator to originate from the upper GI tract; (3) occult GI bleeding, defined as a decrease in hemoglobin ≥2 g/dL or hematocrit ≥10%; (4) symptomatic uncomplicated gastroduodenal ulcer, confirmed by endoscopy or imaging with persistent pain (≥3 days) and no evidence of bleeding; (5) symptomatic gastroduodenal erosive lesions, with persistent pain (≥3 days) and ≥5 gastroduodenal erosions confirmed by endoscopy, excluding mucosal bleeding; (6) upper GI obstruction; and (7) upper GI perforation.

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)

Secondary outcomes

1

Time to First Composite Clinical Event of Upper Gastrointestinal Bleeding as Judged by the Investigator

Time frame
From randomization up to end of study (up to approximately 3 years)
2

Time to First Upper Gastrointestinal Bleeding Event Confirmed by Endoscopy or Imaging, as Adjudicated by the Clinical Event Committee (CEC)

Time frame
From randomization up to end of study (up to approximately 3 years)
3

Time to First Upper Gastrointestinal Bleeding Event of Unclear Origin, as Adjudicated by the Clinical Event Committee (CEC)

Time frame
From randomization up to end of study (up to approximately 3 years)
4

Time to First Occult Gastrointestinal Bleeding Event, as Adjudicated by the Clinical Event Committee (CEC)

Time frame
From randomization up to end of study (up to approximately 3 years)

Other outcomes

1

Subgroup Analyses of the Primary Composite Upper Gastrointestinal Bleeding Event

Exploratory subgroup analyses of the primary efficacy outcome (time to first composite clinical event of upper GI bleeding), performed across the following pre-specified subgroups: (1) timing of zastaprazan initiation relative to onset of ischemic stroke/TIA (acute phase, within 4 weeks vs. subacute phase, after 4 weeks); (2) history of prior gastrointestinal bleeding (yes vs. no); (3) concomitant treatment type (dual antiplatelet therapy vs. anticoagulant therapy); (4) age (\<65 years vs. ≥65 years); (5) baseline renal function (eGFR ≥60 mL/min/1.73m² vs. \<60 mL/min/1.73m²); and (6) stroke mechanism.

Time frame
From randomization up to end of study (up to approximately 3 years)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asan Medical Center

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: