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)
| Registry | NCT07687706, acronym TegoStroke |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: triple, prevention |
| Enrollment | 1524 (Estimated) |
| Sponsor | Hanyang University Guri Hospital (Other); collaborators: HK inno.N Corporation |
| Conditions | Ischemic Stroke, Ischemic Stroke, Acute, Transient Ischemic Attack (TIA), Cerebrovascular Disease, Gastrointestinal Complication, Gastrointestinal Bleeding |
| Interventions | Tegoprazan 50 mg, Placebo (Drug) |
| Dates | start 2026-01-26, primary completion 2027-06-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-07-07, last updated 2026-07-08 |
| Locations | 24 sites in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Ischemic Stroke All trials for Ischemic Stroke, Acute All trials of Tegoprazan 50 mg All trials of Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo | Placebo + Antiplatelet therapy |
| Tegoprazan | Experimental | Drug: Tegoprazan 50 mg | Tegoprazan 50mg daily + Antiplatelet therapy |
Sex: All, ages: 19 Years to any
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:
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |
| Chonnam National University Hospital | Gwangju | South Korea | Recruiting |
| Asan Medical Center | Seoul | South Korea | Recruiting |
| Ewha Womans University Seoul Hospital | Seoul | South Korea | Recruiting |
| Gangnam Severance Hospital | Seoul | South Korea | Recruiting |
| Hanyang University Hospital | Seoul | South Korea | Recruiting |
| Kangdong Sacred Heart Hospital | Seoul | South Korea | Recruiting |
| Korea University Anam Hospital | Seoul | South Korea | Recruiting |
| Korea University Ansan Hospital | Seoul | South Korea | Recruiting |
| Kyung Hee University Hospital | Seoul | South Korea | Recruiting |
| Seoul Metropolitan Government-Seoul National University Boramae Medical Center | Seoul | South Korea | Recruiting |
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
| Ulsan University Hospital | Ulsan | South Korea | Recruiting |