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

Prior treatment

• 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).

Other illness

• 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:

Lab values

• AST, ALT, ALP, or γ-GT ≥5 times the upper limit of normal (ULN), or total bilirubin ≥3 times the ULN at screening.

Other

• Anticipated difficulty in undergoing gastrointestinal endoscopy during the study period.

• 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.