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A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Tegoprazan for Prevention of Gastrointestinal Complication in Ischemic Stroke Patients on Antiplatelet Therapy (TegoStroke)
Sponsor: Hanyang University Guri Hospital
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.
Official title: 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)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1524
Start Date
2026-01-26
Completion Date
2027-12
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
Tegoprazan 50 mg
Tegoprazan 50mg daily + Antiplatelet therapy
Placebo
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