KCT0012421Active, not recruitingPhase 3
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
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Asan Medical Center
- Enrollment
- 984
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Prevention
Eligibility Criteria
- Ages
- 19(Year) to No Limit (—)
- Sex
- All
Inclusion Criteria
- •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:
- •A. 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)
Exclusion Criteria
- •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)
- •Known hypersensitivity to potassium-competitive acid blockers (P-CABs) or to the investigational product
- •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
- •Diagnosis of a condition requiring long-term concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs)
- •Pregnant or breastfeeding women
- •Life expectancy of less than 6 months due to pre-existing comorbid conditions
- •Current participation in another interventional clinical trial that could affect the results of this study
- •Any condition that, in the investigator's judgment, precludes participation
- •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
- •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)
- •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
- •Known hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Investigators
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