Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke

A vizsgálat adatai

Ki végzi

Asan Medical Center

Azonosító

NCT07730840

A regiszteradat frissítve

2026. október 9.

Eredeti leírás

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:A teljes eredeti leírásKevesebb

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

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)

Bevonási feltételek: Adults aged 19 years or older; Onset of transient ischemic attack (TIA) or ischemic stroke within 180 days prior to randomization; Currently initiating or receiving, at the time of randomization, one of the following treatments, with an expected treatment duration of at least 3 weeks:; Dual antiplatelet therapy (DAPT) - aspirin in combination with one of the following: clopidogrel, ticagrelor, prasugrel, or cilostazol B. Oral anticoagulant therapy - a NOAC (apixaban, rivaroxaban, dabigatran, or edoxaban) or warfarin; Provision of written informed consent by the participant (or legally authorized representative).

Kizáró feltételek: Clinically significant peptic ulcer or gastrointestinal bleeding within 1 year prior to enrollment; Diagnosis of a condition requiring long-term concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs); Currently receiving, or having received within 5 half-lives prior to randomization, a prohibited concomitant medication expected to interact with the investigational product (products containing atazanavir, nelfinavir, or rilpivirine); Moderate to severe hepatic impairment (e.g., diagnosis of cirrhosis or confirmed esophageal/gastric varices); History of major gastrointestinal surgery resulting in malabsorption, bowel obstruction, or inability to take oral medication; History of osteoporotic fracture or fragility fracture; Diagnosis of a condition requiring long-term, high-dose systemic corticosteroid therapy; Life expectancy of less than 6 months due to pre-existing comorbid conditions; Any condition that, in the investigator's judgment, precludes participation; History of peptic ulcer complications, including bleeding, perforation, or stricture, regardless of timing; Active bleeding at the time of enrollment, history of a coagulation disorder, or hemodynamic instability at the time of enrollment; 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); Known hypersensitivity to potassium-competitive acid blockers (P-CABs) or to the investigational product; Known hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption; Pregnant or breastfeeding women; Current participation in another interventional clinical trial that could affect the results of this study; Participant or partner of childbearing/reproductive potential who does not agree to use a medically acceptable method of contraception, or to abstain from sexual activity with risk of pregnancy, during the study period.

ClinicalTrials.gov NCT07730840