Tegoprazan to protect the stomach in stroke patients taking antiplatelet medicine
Tests tegoprazan against placebo for stomach problems in people on antiplatelet therapy after stroke.
Plain-language title generated from the registry record
Registry title: Tegoprazan for Prevention of Gastrointestinal Complication in Ischemic Stroke Patients on Antiplatelet Therapy (TegoStroke)
Key facts
- Where
- Anyang-si, Busan, Cheongju-si, Chuncheon, Daegu, Guri-si, Gwangju, Iksan, Jeonju, Seoul, and Ulsan, South KoreaSee the 24 sites
- Phase
- Phase 3
Where in South Korea
- Hallym University Sacred Heart HospitalAnyang-si, South KoreaTaking people
- Dong-A University HospitalBusan, South KoreaTaking people
- Pusan National University HospitalBusan, South KoreaTaking people
- Chungbuk National University HospitalCheongju-si, South KoreaTaking people
- Hallym University Chuncheon Sacred Heart HospitalChuncheon, South KoreaTaking people
- Kangwon National University HospitalChuncheon, South KoreaTaking people
- Keimyung University Dongsan HospitalDaegu, South KoreaTaking people
- Kyungpook National University Chilgok HospitalDaegu, South KoreaTaking people
- Yeungnam University Medical CenterDaegu, South KoreaTaking people
- Hanyang University Guri HospitalGuri-si, South KoreaTaking people
- Chonnam National University HospitalGwangju, South KoreaTaking people
- Wonkwang University HospitalIksan, South KoreaTaking people
- jeonbuk National University HospitalJeonju, South KoreaTaking people
- Asan Medical CenterSeoul, South KoreaTaking people
- Ewha Womans University Seoul HospitalSeoul, South KoreaTaking people
- Gangnam Severance HospitalSeoul, South KoreaTaking people
- Hanyang University HospitalSeoul, South KoreaTaking people
- Kangdong Sacred Heart HospitalSeoul, South KoreaTaking people
- Korea University Anam HospitalSeoul, South KoreaTaking people
- Korea University Ansan HospitalSeoul, South KoreaTaking people
- Kyung Hee University HospitalSeoul, South KoreaTaking people
- Seoul Metropolitan Government Seoul National University Boramae Medical CenterSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Ulsan University HospitalUlsan, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hanyang University Guri Hospital
- Trial code
- NCT07687706
- Record updated
- 8 July 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: Age 19 years or older; 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; Written informed consent provided by the participant or a legally authorized representative; Ability and willingness to understand the study procedures described in the consent form and to comply with the study protocol.
Exclusion: Need for concomitant anticoagulant therapy (transient anticoagulation such as argatroban during the index admission is permitted, with randomization after it is stopped); 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; 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.); Current use of, or use within five half-lives of, a contraindicated interacting drug (atazanavir, nelfinavir, rilpivirine, and preparations containing these components); 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; Hypersensitivity or contraindication to a P-CAB or to benzimidazoles; Any other condition deemed by the investigators to render the patient unsuitable for study participation, including but not limited to:; AST, ALT, ALP, or γ-GT ≥5 times the upper limit of normal (ULN), or total bilirubin ≥3 times the ULN at screening; Anticipated difficulty in undergoing gastrointestinal endoscopy during the study period.