None listed
Conditions
Interventions
Drug : The interventions in this clinical trial consist of a tegoprazan 50 mg group administered orally once daily and a placebo group with identical appearance and dosing conditions. Participants are
in cases requiring a wash-out period due to prohibited concomitant medications, randomization may be performed within 5 weeks provided informed consent is obtained within 7 days. Study medication is i
Sponsors
Hanyang University Guri Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged 19 years or older Patients hospitalized with acute ischemic stroke or transient ischemic attack (TIA), who are initiating antiplatelet therapy for the first time, are expected to continue antiplatelet therapy for at least 6 months, and are within 7 days of symptom onset Exceptionally, for patients requiring a wash-out period for prohibited concomitant medications listed in Section 5.7, informed consent must be obtained within 7 days of symptom onset, wash-out must be conducted, and randomization must occur within 5 weeks of symptom onset. Long-term antiplatelet therapy in acute ischemic stroke patients should follow standard stroke treatment guidelines and be determined by the investigator’s clinical judgment. Patients who voluntarily agree to participate in the study prior to undergoing any study-related procedures If the patient is unable to provide written informed consent, the patient must verbally assent to participate, and written informed consent must be obtained from the patient’s legally authorized representative (LAR). This process must be properly documented. Patients who understand the procedures described in the informed consent form and are willing and able to comply with the protocol requirements
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from participation in this study: History of peptic ulcer diagnosis or gastrointestinal bleeding within the past 1 year Patients requiring concomitant antiplatelet and anticoagulant therapy Exception: Patients temporarily receiving anticoagulation (e.g., argatroban) during index admission may be randomized after discontinuation of anticoagulant therapy Patients considered unlikely to undergo upper GI endoscopy during the study period Use of or indication for the following medications within 4 weeks prior to randomization or during index admission: Potassium-competitive acid blockers (P-CAB), proton pump inhibitors (PPI), H2-receptor antagonists (H2RA), or sucralfate Exception: Eligible if =4 weeks wash-out after discontinuation Known hypersensitivity or contraindication to P-CABs or benzimidazole derivatives Screening laboratory values: AST, ALT, ALP, or ?-GT =5× upper limit of normal (ULN), or total bilirubin =3× ULN Exception: CTCAE Grade 1–2 (AST, ALT, ALP, ?-GT <5× ULN; total bilirubin <3× ULN) permitted Participation in another clinical study, except: Participation in a study affecting efficacy/safety evaluation of this trial within the past 12 months Receipt of an investigational drug/procedure not part of standard of care within the past 12 months Participation in a trial that may pose additional risk within the past 12 months Current or recent (within 5 half-lives) use of contraindicated medications expected to interact with the study drug (atazanavir, nelfinavir, rilpivirine, or formulations containing these agents) Other reasons deemed inappropriate by the investigator, including but not limited to: Active bleeding, severe thrombocytopenia (platelet count <50,000/mm³), congenital/acquired coagulation disorders Hemodynamically unstable condition Pregnant or lactating women Women of childbearing potential must not be pregnant and must use at least one protocol-specified contraceptive method during study drug administration; non-childbearing women are exempt History of GI disease precluding P-CAB use (e.g., prior esophageal/gastric/duodenal surgery, Zollinger-Ellison syndrome, major esophageal motility disorders) Exception: patients with prior simple perforation repair, appendectomy, cholecystectomy, or endoscopic benign tumor resection may be included Patients on dialysis or with eGFR <15 mL/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Upper gastrointestinal bleeding (UGIB) or gastrointestinal bleeding of undetermined origin (upper or lower)* Upper gastrointestinal bleeding or gastrointestinal bleeding of undetermined origin: A. Definite UGIB confirmed by upper endoscopy or computed tomography (CT) B. Definite UGIB of unknown cause C. Gastrointestinal bleeding suspected when hemoglobin decreases by =2 g/dL or hematocrit decreases by =10%, provided that the presumptive cause is not hemorrhoidal, anal, or diverticular bleeding Gastric ulcer =3 mm in diameter confirmed by upper endoscopy Duodenal ulcer =3 mm in diameter confirmed by upper endoscopy Erosive esophagitis confirmed by upper endoscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of GERD (Los Angeles classification, LA grade);Degree of gastric mucosal injury (Lanza Score);Change in gastrointestinal symptom severity score (Gastrointestinal Symptom Rating Scale, GSRS) before and after the clinical trial;Change in reflux disease symptoms (Reflux Disease Questionnaire, RDQ) score before and after the clinical trial;Occurrence of gastrointestinal symptoms (e.g., chest pain, heartburn) requiring pharmacological treatment (proton pump inhibitors, H2-receptor antagonists, alginate, or magnesium-aluminum complex);Occurrence of upper gastrointestinal bleeding;Occurrence of gastrointestinal bleeding of undetermined origin (upper or lower);Occurrence of erosive esophagitis confirmed by upper endoscopy;Incidence of adverse events (AEs) during the study period;Incidence of adverse drug reactions (ADRs) related to the investigational product;Incidence of serious adverse events (SAEs);Incidence of adverse events by severity;Laboratory tests;Vital signs and physical examinations | — |
Countries
Korea, Republic of
Contacts
Public ContactSeong-Ho Koh
Hanyang University Guri Hospital
Outcome results
None listed