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

NCT07687706 | Recruiting Phase 3

• 1 other identifier: TEGOSTROKE-P3-001
• Study Type: interventional
• Target: 1,524
• Locations: 1 country
• Sites: 24

Brief Summary

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.

Conditions

Ischemic Stroke; Gastrointestinal Bleeding; Gastrointestinal Complication; Ischemic Stroke, Acute; Transient Ischemic Attack (TIA); Cerebrovascular Disease

Keywords

Gastrointestinal Complication; Gastroprotection; Gastrointestinal Gleeding; Ischemic Stroke; Transient Ischemic Attack; Cerebrovascular Disease

Outcome Measures

Primary Outcomes (1)

• Composite gastrointestinal complication

  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

Secondary Outcomes (9)

• Upper GI bleeding

  180 days

• GI bleeding of unknown upper/lower origin

  180 days

• Gastric ulcer

  180 days

• Duodenal ulcer

  180 days

• Erosive esophagitis severity

  180 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo + Antiplatelet therapy

Drug: Placebo

Tegoprazan

EXPERIMENTAL

Tegoprazan 50mg daily + Antiplatelet therapy

Drug: Tegoprazan 50 mg

Interventions

Tegoprazan 50 mg DRUG

Tegoprazan 50mg daily + Antiplatelet therapy

Tegoprazan

Placebo DRUG

Placebo drug + Antiplatelet therapy

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Hanyang University Guri Hospital: lead
• HK inno.N Corporation: collaborator

Study Sites (24)

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

Related Publications (11)

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  PMID: 34227708 BACKGROUND

• 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.

  PMID: 32701188 BACKGROUND

• 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.

  PMID: 24326741 BACKGROUND

• 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.

  PMID: 34024117 BACKGROUND

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  PMID: 39210710 BACKGROUND

• 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.

  PMID: 18637091 BACKGROUND

• 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.

  PMID: 19577798 BACKGROUND

• 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.

  PMID: 20925534 BACKGROUND

• 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.

  PMID: 34752902 BACKGROUND

• 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.

  PMID: 41582814 BACKGROUND

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  PMID: 37471501 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Cerebrovascular Disorders; Gastrointestinal Hemorrhage

Interventions

tegoprazan

Condition Hierarchy (Ancestors)

Stroke; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Seong-Ho Koh, MD, PhD

CONTACT

+82-31-560-2267; ksh213@hanyang.ac.kr

Jiyeon Ha, MD

CONTACT

hjy9307@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (24)