RecruitingPhase 3NCT07687706

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

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Superiority, Investigator-initiated Trial of Tegoprazan for Prevention of Gastrointestinal Complication in Ischemic Stroke Patients on Antiplatelet Therapy (TegoStroke)


Sponsor

Hanyang University Guri Hospital

Enrollment

1,524 participants

Start Date

Jan 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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. Adult patients who are starting antiplatelet therapy after acute ischemic stroke or transient ischemic attack, and who are expected to continue it for at least 6 months, will be included. Eligible patients will be 1:1 randomized to receive oral tegoprazan 50 mg once daily or matching placebo for 180 days. The primary outcome is a composite of upper or indeterminate-origin gastrointestinal bleeding, gastric or duodenal ulcer ≥3 mm, or erosive esophagitis, ascertained up to a day-180 esophagogastroduodenoscopy. This study would provide the first randomized evidence on routine gastroprotection for patients on antiplatelet therapy after ischemic stroke.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Tegoprazan 50 mg for people with cerebrovascular disease, gastrointestinal bleeding, and other related conditions. The study is currently recruiting participants at 24 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTegoprazan 50 mg

Tegoprazan 50mg daily + Antiplatelet therapy

DRUGPlacebo

Placebo drug + Antiplatelet therapy


Locations(24)

Pusan National University Hospital

Busan, Busan, South Korea

Keimyung University Dongsan Hospital

Daegu, Daegu, South Korea

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Kangwon National University Hospital

Chuncheon, Gangwon-do, South Korea

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Wonkwang University Hospital

Iksan, Jeollabuk-do, South Korea

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Dong-A University Hospital

Busan, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Yeungnam University Medical Center

Daegu, South Korea

Hanyang University Guri Hospital

Guri-si, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Asan Medical Center

Seoul, South Korea

Ewha Womans University Seoul Hospital

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Hanyang University Hospital

Seoul, South Korea

Kangdong Sacred Heart Hospital

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Korea University Ansan Hospital

Seoul, South Korea

Kyung Hee University Hospital

Seoul, South Korea

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Ulsan University Hospital

Ulsan, South Korea

View Full Details on ClinicalTrials.gov

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NCT07687706


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