Tegoprazan for Prevention of Gastrointestinal Complication in Ischemic Stroke Patients on Antiplatelet Therapy (TegoStroke) (TegoStroke)
7. juli 2026 opdateret af: SEONG-HO KOH, Hanyang University Guri Hospital
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1524
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Seong-Ho Koh, MD, PhD
- Telefonnummer: +82-31-560-2267
- E-mail: ksh213@hanyang.ac.kr
Undersøgelse Kontakt Backup
- Navn: Jiyeon Ha, MD
- E-mail: hjy9307@gmail.com
Studiesteder
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-
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Busan, Sydkorea
- Rekruttering
- Dong-A University Hospital
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Daegu, Sydkorea
- Rekruttering
- Kyungpook National University Chilgok Hospital
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Daegu, Sydkorea
- Rekruttering
- Yeungnam University Medical Center
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Guri-si, Sydkorea
- Rekruttering
- Hanyang University Guri Hospital
-
Kontakt:
- Seong-Ho Koh, MD, PhD
- E-mail: ksh213@hanyang.ac.kr
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Gwangju, Sydkorea
- Rekruttering
- Chonnam National University Hospital
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Seoul, Sydkorea
- Rekruttering
- Seoul National University Hospital
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Seoul, Sydkorea
- Rekruttering
- Asan Medical Center
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Seoul, Sydkorea
- Rekruttering
- Korea University Anam Hospital
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Seoul, Sydkorea
- Rekruttering
- Ewha Womans University Seoul Hospital
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Seoul, Sydkorea
- Rekruttering
- Gangnam Severance Hospital
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Seoul, Sydkorea
- Rekruttering
- Kyung Hee University Hospital
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Seoul, Sydkorea
- Rekruttering
- Hanyang University Hospital
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Seoul, Sydkorea
- Rekruttering
- Kangdong Sacred Heart Hospital
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Seoul, Sydkorea
- Rekruttering
- Korea University Ansan Hospital
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Seoul, Sydkorea
- Rekruttering
- Seoul Metropolitan Government-Seoul National University Boramae Medical Center
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Ulsan, Sydkorea
- Rekruttering
- Ulsan University Hospital
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Busan
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Busan, Busan, Sydkorea
- Rekruttering
- Pusan National University Hospital
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-
Daegu
-
Daegu, Daegu, Sydkorea
- Rekruttering
- Keimyung University Dongsan Hospital
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Gangwon-do
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Chuncheon, Gangwon-do, Sydkorea
- Rekruttering
- Kangwon National University Hospital
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Chuncheon, Gangwon-do, Sydkorea
- Rekruttering
- Hallym University Chuncheon Sacred Heart Hospital
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Gyeonggi-do
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Anyang-si, Gyeonggi-do, Sydkorea
- Rekruttering
- Hallym University Sacred Heart Hospital
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-
Jeollabuk-do
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Iksan, Jeollabuk-do, Sydkorea
- Rekruttering
- Wonkwang University Hospital
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Jeonju, Jeollabuk-do, Sydkorea
- Rekruttering
- Jeonbuk National University Hospital
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North Chungcheong
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Cheongju-si, North Chungcheong, Sydkorea
- Rekruttering
- Chungbuk National University Hospital
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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 Criteria:
- 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.
- Need for concomitant anticoagulant therapy (transient anticoagulation such as argatroban during the index admission is permitted, with randomization after it is stopped)
- Anticipated difficulty in undergoing gastrointestinal endoscopy during the study period.
- 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.
- Hypersensitivity or contraindication to a P-CAB or to benzimidazoles.
- AST, ALT, ALP, or γ-GT ≥5 times the upper limit of normal (ULN), or total bilirubin ≥3 times the ULN at screening.
- 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).
- Any other condition deemed by the investigators to render the patient unsuitable for study participation, including but not limited to:
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Placebo + Antiplatelet therapy
|
Placebo drug + Antiplatelet therapy
|
|
Eksperimentel: Tegoprazan
Tegoprazan 50mg daily + Antiplatelet therapy
|
Tegoprazan 50mg daily + Antiplatelet therapy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Composite gastrointestinal complication
Tidsramme: 180 days
|
Composite of upper or indeterminate origin gastrointestinal bleeding, gastric or duodenal ulcer ≥3 mm, or erosive esophagitis, ascertained up to a day-180 esophagogastroduodenoscopy
|
180 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Upper GI bleeding
Tidsramme: 180 days
|
overt upper GI bleeding confirmed by endoscopy or CT, overt upper GI bleeding of unknown source
|
180 days
|
|
GI bleeding of unknown upper/lower origin
Tidsramme: 180 days
|
Hemoglobin fall ≥2 g/dL or hematocrit fall ≥10% presumed to be GI in origin without a likely hemorrhoidal, anal, or diverticular source.
|
180 days
|
|
Gastric ulcer
Tidsramme: 180 days
|
Gastric ulcer ≥3 mm in diameter on esophagogastroduodenoscopy
|
180 days
|
|
Duodenal ulcer
Tidsramme: 180 days
|
Duodenal ulcer ≥3 mm in diameter on esophagogastroduodenoscopy
|
180 days
|
|
Erosive esophagitis severity
Tidsramme: 180 days
|
Erosive esophagitis severity by Los Angeles grade on esophagogastroduodenoscopy
|
180 days
|
|
Gastric mucosal injury
Tidsramme: 180 days
|
Gastric mucosal injury by the modified Lanza score on esophagogastroduodenoscopy
|
180 days
|
|
Gastrointestinal Symptom Rating Scale score
Tidsramme: 180 days
|
Change of Gastrointestinal Symptom Rating Scale (GSRS) score
|
180 days
|
|
Change of Reflux Disease Questionnaire (RDQ) score
Tidsramme: 180 days
|
Change of Reflux Disease Questionnaire (RDQ) score
|
180 days
|
|
GI symptoms requiring medication
Tidsramme: 180 days
|
occurrence of gastrointestinal symptoms requiring medication (e.g., chest pain, heartburn)
|
180 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Bhatt DL, Cryer BL, Contant CF, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Scirica BM, Murphy SA, Cannon CP; COGENT Investigators. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010 Nov 11;363(20):1909-17. doi: 10.1056/NEJMoa1007964. Epub 2010 Oct 6.
- Cho YK, Choi MG, Choi SC, Lee KM, Kim TO, Park SH, Moon JS, Lim YJ, Kang DH, Cheon GJ, Baik GH, Kim KO, Cho KB, Jang JS, Park JJ, Son BK, Jung HK, Kim BW, Kim SK, Lee ST, Cha JM, Kim AR, Kim EJ, Park HW, Song GS. Randomised clinical trial: tegoprazan, a novel potassium-competitive acid blocker, or lansoprazole in the treatment of gastric ulcer. Aliment Pharmacol Ther. 2020 Sep;52(5):789-797. doi: 10.1111/apt.15865. Epub 2020 Jul 23.
- Han Y, Liao Z, Li Y, Zhao X, Ma S, Bao D, Qiu M, Deng J, Wang J, Qu P, Jiang C, Jia S, Yang S, Ru L, Feng J, Gao W, Huang Y, Tao L, Han Y, Yang K, Wang X, Zhang W, Wang B, Li Y, Yang Y, Li J, Sheng J, Ma Y, Cui M, Ma S, Wang X, Li Z, Stone GW. Magnetically Controlled Capsule Endoscopy for Assessment of Antiplatelet Therapy-Induced Gastrointestinal Injury. J Am Coll Cardiol. 2022 Jan 18;79(2):116-128. doi: 10.1016/j.jacc.2021.10.028. Epub 2021 Nov 6.
- Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
- Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
- Virani SS, Newby LK, Arnold SV, Bittner V, Brewer LC, Demeter SH, Dixon DL, Fearon WF, Hess B, Johnson HM, Kazi DS, Kolte D, Kumbhani DJ, LoFaso J, Mahtta D, Mark DB, Minissian M, Navar AM, Patel AR, Piano MR, Rodriguez F, Talbot AW, Taqueti VR, Thomas RJ, van Diepen S, Wiggins B, Williams MS; Peer Review Committee Members. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2023 Aug 29;148(9):e9-e119. doi: 10.1161/CIR.0000000000001168. Epub 2023 Jul 20.
- Prabhakaran S, Gonzalez NR, Zachrison KS, Adeoye O, Alexandrov AW, Ansari SA, Chapman S, Czap AL, Dumitrascu OM, Ishida K, Jadhav AP, Johnson B, Johnston KC, Khatri P, Kimberly WT, Lee VH, Leslie-Mazwi TM, Mac Grory B, Madsen TE, Menon B, Mistry EA, Park S, Parker S, Perez de la Ossa N, Reeves M, Saiz T, Scott PA, Schwartzberg D, Sheth SA, Sporns PB, Times S, Tjoumakaris S, Wolfe SQ, Yaghi S; Peer Review Committee. 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2026 Jan 26. doi: 10.1161/STR.0000000000000513. Online ahead of print.
- Kim SH, Cho KB, Chun HJ, Lee SW, Kwon JG, Lee DH, Kim SG, Jung HY, Kim JW, Lee JS, Park H, Choi SC, Jee SR, Kim HS, Ko KH, Park SJ, Lee YC, Park SH, Kim AR, Kim EJ, Park HW, Kim BT, Song GS. Randomised clinical trial: comparison of tegoprazan and placebo in non-erosive reflux disease. Aliment Pharmacol Ther. 2021 Aug;54(4):402-411. doi: 10.1111/apt.16477. Epub 2021 Jul 6.
- Sugano K, Choi MG, Lin JT, Goto S, Okada Y, Kinoshita Y, Miwa H, Chiang CE, Chiba T, Hori M, Fukushima Y, Kim HS, Chang CY, Date M; LAVENDER Study Group. Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study. Gut. 2014 Jul;63(7):1061-8. doi: 10.1136/gutjnl-2013-304722. Epub 2013 Dec 10.
- Yeomans N, Lanas A, Labenz J, van Zanten SV, van Rensburg C, Racz I, Tchernev K, Karamanolis D, Roda E, Hawkey C, Naucler E, Svedberg LE. Efficacy of esomeprazole (20 mg once daily) for reducing the risk of gastroduodenal ulcers associated with continuous use of low-dose aspirin. Am J Gastroenterol. 2008 Oct;103(10):2465-73. doi: 10.1111/j.1572-0241.2008.01995.x. Epub 2008 Jul 12.
- Taha AS, McCloskey C, Prasad R, Bezlyak V. Famotidine for the prevention of peptic ulcers and oesophagitis in patients taking low-dose aspirin (FAMOUS): a phase III, randomised, double-blind, placebo-controlled trial. Lancet. 2009 Jul 11;374(9684):119-25. doi: 10.1016/S0140-6736(09)61246-0. Epub 2009 Jul 3.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. januar 2026
Primær færdiggørelse (Anslået)
1. juni 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
30. juni 2026
Først indsendt, der opfyldte QC-kriterier
30. juni 2026
Først opslået (Faktiske)
7. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Karsygdomme
- Hjerte-kar-sygdomme
- Patologiske processer
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Blødning
- Hjerneiskæmi
- Slag
- Patologiske tilstande, tegn og symptomer
- Iskæmisk slagtilfælde
- Iskæmisk angreb, forbigående
- Cerebrovaskulære lidelser
- Gastrointestinal blødning
- Tegoprazan
Andre undersøgelses-id-numre
- TEGOSTROKE-P3-001
Plan for individuelle deltagerdata (IPD)
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