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Ischemic StrokePhase 3TegoStrokeNCT07687706

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

A Phase 3 study testing Tegoprazan 50 mg in people with Ischemic Stroke and Ischemic Stroke, Acute, run by Hanyang University Guri Hospital at 24 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Tegoprazan 50 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,524 participants
Where
24 sitesSouth Korea
Study dates
26 Jan 2026to Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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:

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Seong-Ho Koh, MD, PhD contact

+82-31-560-2267

ksh213@hanyang.ac.kr

Jiyeon Ha, MD contact

hjy9307@gmail.com

24 sites in 1 country

South Korea24 sites, 24 recruiting

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do

    Recruiting

  • Pusan National University Hospital

    Busan, Busan

    Recruiting

  • Dong-A University Hospital

    Busan

    Recruiting

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong

    Recruiting

  • Hallym University Chuncheon Sacred Heart Hospital

    Chuncheon, Gangwon-do

    Recruiting

  • Kangwon National University Hospital

    Chuncheon, Gangwon-do

    Recruiting

  • Keimyung University Dongsan Hospital

    Daegu, Daegu

    Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu

    Recruiting

  • Yeungnam University Medical Center

    Daegu

    Recruiting

  • Hanyang University Guri Hospital

    Guri-si

    Seong-Ho Koh, MD, PhD, ksh213@hanyang.ac.kr

    Recruiting

  • Chonnam National University Hospital

    Gwangju

    Recruiting

  • Wonkwang University Hospital

    Iksan, Jeollabuk-do

    Recruiting

  • Jeonbuk National University Hospital

    Jeonju, Jeollabuk-do

    Recruiting

  • Asan Medical Center

    Seoul

    Recruiting

  • Ewha Womans University Seoul Hospital

    Seoul

    Recruiting

  • Gangnam Severance Hospital

    Seoul

    Recruiting

  • Hanyang University Hospital

    Seoul

    Recruiting

  • Kangdong Sacred Heart Hospital

    Seoul

    Recruiting

  • Korea University Anam Hospital

    Seoul

    Recruiting

  • Korea University Ansan Hospital

    Seoul

    Recruiting

  • Kyung Hee University Hospital

    Seoul

    Recruiting

  • Seoul Metropolitan Government-Seoul National University Boramae Medical Center

    Seoul

    Recruiting

  • Seoul National University Hospital

    Seoul

    Recruiting

  • Ulsan University Hospital

    Ulsan

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Being tested
Tegoprazan 50 mg, Placebo
Keywords
Gastrointestinal Complication, Gastroprotection, Gastrointestinal Gleeding, Ischemic Stroke, Transient Ischemic Attack, Cerebrovascular Disease
Medical subject headings
Ischemic Stroke, Ischemic Attack, Transient, Cerebrovascular Disorders, Gastrointestinal Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tegoprazan 50 mgDrug

    Tegoprazan 50mg daily + Antiplatelet therapy

  • PlaceboDrug

    Placebo drug + Antiplatelet therapy

Study groups in NCT07687706
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo + Antiplatelet therapy
Receives: Drug: Placebo
TegoprazanExperimentalTegoprazan 50mg daily + Antiplatelet therapy
Receives: Drug: Tegoprazan 50 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 180 days

Secondary outcomes (9)

  1. Upper GI bleeding

    overt upper GI bleeding confirmed by endoscopy or CT, overt upper GI bleeding of unknown source

    Measured: 180 days

  2. GI bleeding of unknown upper/lower origin

    Hemoglobin fall ≥2 g/dL or hematocrit fall ≥10% presumed to be GI in origin without a likely hemorrhoidal, anal, or diverticular source.

    Measured: 180 days

  3. Gastric ulcer

    Gastric ulcer ≥3 mm in diameter on esophagogastroduodenoscopy

    Measured: 180 days

  4. Duodenal ulcer

    Duodenal ulcer ≥3 mm in diameter on esophagogastroduodenoscopy

    Measured: 180 days

  5. Erosive esophagitis severity

    Erosive esophagitis severity by Los Angeles grade on esophagogastroduodenoscopy

    Measured: 180 days

  6. Gastric mucosal injury

    Gastric mucosal injury by the modified Lanza score on esophagogastroduodenoscopy

    Measured: 180 days

  7. Gastrointestinal Symptom Rating Scale score

    Change of Gastrointestinal Symptom Rating Scale (GSRS) score

    Measured: 180 days

  8. Change of Reflux Disease Questionnaire (RDQ) score

    Change of Reflux Disease Questionnaire (RDQ) score

    Measured: 180 days

  9. GI symptoms requiring medication

    occurrence of gastrointestinal symptoms requiring medication (e.g., chest pain, heartburn)

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start26 Jan 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,524 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07687706
Sponsor's protocol ID
TEGOSTROKE-P3-001
Acronym
TegoStroke
Status last verified
Jul 2026
First submitted
30 Jun 2026
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34227708

  • 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.

    PubMed 32701188

  • 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.

    PubMed 24326741

  • 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.

    PubMed 34024117

  • 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.

    PubMed 39210710

  • 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.

    PubMed 18637091

  • 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.

    PubMed 19577798

  • 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.

    PubMed 20925534

  • 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.

    PubMed 34752902

  • 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 Aug;57(8):e316-e436. doi: 10.1161/STR.0000000000000513. Epub 2026 Jan 26.

    PubMed 41582814

  • 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.

    PubMed 37471501

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tegoprazan 50 mg in people with Ischemic Stroke and Ischemic Stroke, Acute, run by Hanyang University Guri Hospital at 24 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seong-Ho Koh, MD, PhD (+82-31-560-2267, ksh213@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite gastrointestinal complication (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07687706, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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