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Tegoprazan for Prevention of Gastrointestinal Complication in Ischemic Stroke Patients on Antiplatelet Therapy (TegoStroke)

RecruitingPhase 3Ages 19 Years - anyAllHanyang University Guri Hospital
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In plain words

What the trial is, and whether it could suit you

Patients with ischemic stroke commonly receive antiplatelet therapy, frequently starting as dual antiplatelet therapy, which is associated with an increased risk of gastrointestinal complications. Although evidence for gastroprotection is established in coronary artery disease, no comparable guidance or evidence exists for stroke care. Tegoprazan is a potassium-competitive acid blocker offering rapid, meal-independent acid suppression with fewer drug interactions than proton pump inhibitors, yet whether it prevents such complications after stroke remains unknown. Thus, the investigators aim to evaluate whether tegoprazan reduces gastrointestinal complications in patients receiving antiplatelet therapy after ischemic stroke. TegoStroke is a phase 3, multicenter, randomized, double-blind, placebo-controlled, superiority trial conducted at more than 20 centers in the Republic of Korea. Adu

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 19 years or older. 2. Hospitalization for acute ischemic stroke or transient ischemic attack, with antiplatelet therapy initiated for the first time, expected to continue for at least 6 months at the treating physician's discretion per relevant stroke guidelines, and within 4 weeks of the first antiplatelet dose at the time of randomization. 3. Written informed consent provided by the participant or a legally authorized representative. 4. Ability and willingness to understand the study procedures described in the consent form and to comply with the study protocol. Exclusion Criteria: 1. History of peptic ulcer disease diagnosis or gastrointestinal bleeding within the past year. At screening, the history and findings of any EGD performed within the preceding 2 years were obtained by participant interview. 2. Need for concomitant anticoagulant therapy (transient anticoagulation such as argatroban during the index admission is permitted, with randomization after it is stopped) 3. Anticipated difficulty in undergoing gastrointestinal endoscopy during the study period. 4. Use of a P-CAB, PPI, or H2-receptor antagonist within 1 week before randomization, or an active indication for these agents, a mucosal protectant, or an antacid at enrollment. Temporary use of these agents during acute care in the index admission, since discontinued and without a current indication, is not exclusionary. 5. Hypersensitivity or contraindication to a P-CAB or to benzimidazoles. 6. AST, ALT, ALP, or γ-GT ≥5 times the upper limit of normal (ULN), or total bilirubin ≥3 times the ULN at screening. 7. Participation within the past 12 months in any of the following: (1) a clinical study that may affect the efficacy or safety assessments of the present study; (2) a study involving an investigational product or procedure not administered under standard-of-care guidelines; (3) a study that may pose additional risk to the participant. (Participation in other clinical studies is otherwise permitted.) 8. Current use of, or use within five half-lives of, a contraindicated interacting drug (atazanavir, nelfinavir, rilpivirine, and preparations containing these components). 9. Any other condition deemed by the investigators to render the patient unsuitable for study participation, including but not limited to:
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What it tests

  • Tegoprazan 50 mg
  • Placebo
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Where

24 sites
Pusan National University Hospital
Busan, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, South Korea
Wonkwang University Hospital
Iksan, South Korea
Jeonbuk National University Hospital
Jeonju, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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