Condition: Ischemic Stroke · Ischemic Stroke, Acute · Transient Ischemic Attack (TIA) · Sponsor: Hanyang University Guri Hospital
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 p…
This description comes directly from the study's public registry record.
Seong-Ho Koh, MD, PhD · +82-31-560-2267 · ksh213@hanyang.ac.kr
Jiyeon Ha, MD · hjy9307@gmail.com
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| Pusan National University Hospital | Busan, Busan, South Korea | Recruiting |
| Keimyung University Dongsan Hospital | Daegu, Daegu, South Korea | Recruiting |
| Hallym University Chuncheon Sacred Heart Hospital | Chuncheon, Gangwon-do, South Korea | Recruiting |
| Kangwon National University Hospital | Chuncheon, Gangwon-do, South Korea | Recruiting |
| Hallym University Sacred Heart Hospital | Anyang-si, Gyeonggi-do, South Korea | Recruiting |
| Wonkwang University Hospital | Iksan, Jeollabuk-do, South Korea | Recruiting |
| Jeonbuk National University Hospital | Jeonju, Jeollabuk-do, South Korea | Recruiting |
| Chungbuk National University Hospital | Cheongju-si, North Chungcheong, South Korea | Recruiting |
| Dong-A University Hospital | Busan, South Korea | Recruiting |
| Kyungpook National University Chilgok Hospital | Daegu, South Korea | Recruiting |
| Yeungnam University Medical Center | Daegu, South Korea | Recruiting |
| Hanyang University Guri Hospital | Guri-si, South Korea | Recruiting |
+ 12 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07687706