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

July 7, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1524

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
      • Busan, South Korea
        • Recruiting
        • Dong-A University Hospital
      • Daegu, South Korea
        • Recruiting
        • Kyungpook National University Chilgok Hospital
      • Daegu, South Korea
        • Recruiting
        • Yeungnam University Medical Center
      • Guri-si, South Korea
        • Recruiting
        • Hanyang University Guri Hospital
        • Contact:
      • Gwangju, South Korea
        • Recruiting
        • Chonnam National University Hospital
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
      • Seoul, South Korea
        • Recruiting
        • Korea University Anam Hospital
      • Seoul, South Korea
        • Recruiting
        • Ewha Womans University Seoul Hospital
      • Seoul, South Korea
        • Recruiting
        • Gangnam Severance Hospital
      • Seoul, South Korea
        • Recruiting
        • Kyung Hee University Hospital
      • Seoul, South Korea
        • Recruiting
        • Hanyang University Hospital
      • Seoul, South Korea
        • Recruiting
        • Kangdong Sacred Heart Hospital
      • Seoul, South Korea
        • Recruiting
        • Korea University Ansan Hospital
      • Seoul, South Korea
        • Recruiting
        • Seoul Metropolitan Government-Seoul National University Boramae Medical Center
      • Ulsan, South Korea
        • Recruiting
        • Ulsan University Hospital
    • Busan
      • Busan, Busan, South Korea
        • Recruiting
        • Pusan National University Hospital
    • Daegu
      • Daegu, Daegu, South Korea
        • Recruiting
        • Keimyung University Dongsan Hospital
    • Gangwon-do
      • Chuncheon, Gangwon-do, South Korea
        • Recruiting
        • Kangwon National University Hospital
      • Chuncheon, Gangwon-do, South Korea
        • Recruiting
        • Hallym University Chuncheon Sacred Heart Hospital
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, South Korea
        • Recruiting
        • Hallym University Sacred Heart Hospital
    • Jeollabuk-do
      • Iksan, Jeollabuk-do, South Korea
        • Recruiting
        • Wonkwang University Hospital
      • Jeonju, Jeollabuk-do, South Korea
        • Recruiting
        • Jeonbuk National University Hospital
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea
        • Recruiting
        • Chungbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 19 years or older.
  2. 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.
  3. Written informed consent provided by the participant or a legally authorized representative.
  4. Ability and willingness to understand the study procedures described in the consent form and to comply with the study protocol.

Exclusion Criteria:

  1. 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.
  2. Need for concomitant anticoagulant therapy (transient anticoagulation such as argatroban during the index admission is permitted, with randomization after it is stopped)
  3. Anticipated difficulty in undergoing gastrointestinal endoscopy during the study period.
  4. 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.
  5. Hypersensitivity or contraindication to a P-CAB or to benzimidazoles.
  6. AST, ALT, ALP, or γ-GT ≥5 times the upper limit of normal (ULN), or total bilirubin ≥3 times the ULN at screening.
  7. 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.)
  8. Current use of, or use within five half-lives of, a contraindicated interacting drug (atazanavir, nelfinavir, rilpivirine, and preparations containing these components).
  9. Any other condition deemed by the investigators to render the patient unsuitable for study participation, including but not limited to:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo + Antiplatelet therapy
Drug: Placebo
Placebo drug + Antiplatelet therapy
Experimental: Tegoprazan
Tegoprazan 50mg daily + Antiplatelet therapy
Drug: Tegoprazan 50 mg
Tegoprazan 50mg daily + Antiplatelet therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite gastrointestinal complication
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper GI bleeding
Time Frame: 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
Time Frame: 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
Time Frame: 180 days
Gastric ulcer ≥3 mm in diameter on esophagogastroduodenoscopy
180 days
Duodenal ulcer
Time Frame: 180 days
Duodenal ulcer ≥3 mm in diameter on esophagogastroduodenoscopy
180 days
Erosive esophagitis severity
Time Frame: 180 days
Erosive esophagitis severity by Los Angeles grade on esophagogastroduodenoscopy
180 days
Gastric mucosal injury
Time Frame: 180 days
Gastric mucosal injury by the modified Lanza score on esophagogastroduodenoscopy
180 days
Gastrointestinal Symptom Rating Scale score
Time Frame: 180 days
Change of Gastrointestinal Symptom Rating Scale (GSRS) score
180 days
Change of Reflux Disease Questionnaire (RDQ) score
Time Frame: 180 days
Change of Reflux Disease Questionnaire (RDQ) score
180 days
GI symptoms requiring medication
Time Frame: 180 days
occurrence of gastrointestinal symptoms requiring medication (e.g., chest pain, heartburn)
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University Guri Hospital

Collaborators

HK inno.N Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEGOSTROKE-P3-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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