Tegoprazan for Prevention of Gastrointestinal Complication in Ischemic Stroke Patients on Antiplatelet Therapy (TegoStroke) (TegoStroke)
2026년 7월 7일 업데이트: 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.
연구 개요
상태
모병
개입 / 치료
연구 유형
중재적
등록 (추정된)
1524
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Seong-Ho Koh, MD, PhD
- 전화번호: +82-31-560-2267
- 이메일: ksh213@hanyang.ac.kr
연구 연락처 백업
- 이름: Jiyeon Ha, MD
- 이메일: hjy9307@gmail.com
연구 장소
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Busan, 대한민국
- 모병
- Dong-A University Hospital
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Daegu, 대한민국
- 모병
- Kyungpook National University Chilgok Hospital
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Daegu, 대한민국
- 모병
- Yeungnam University Medical Center
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Guri-si, 대한민국
- 모병
- Hanyang University Guri Hospital
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연락하다:
- Seong-Ho Koh, MD, PhD
- 이메일: ksh213@hanyang.ac.kr
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Gwangju, 대한민국
- 모병
- Chonnam National University Hospital
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Seoul, 대한민국
- 모병
- Seoul National University Hospital
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Seoul, 대한민국
- 모병
- Asan Medical Center
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Seoul, 대한민국
- 모병
- Korea University Anam Hospital
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Seoul, 대한민국
- 모병
- Ewha Womans University Seoul Hospital
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Seoul, 대한민국
- 모병
- Gangnam Severance Hospital
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Seoul, 대한민국
- 모병
- Kyung Hee University Hospital
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Seoul, 대한민국
- 모병
- Hanyang University Hospital
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Seoul, 대한민국
- 모병
- Kangdong Sacred Heart Hospital
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Seoul, 대한민국
- 모병
- Korea University Ansan Hospital
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Seoul, 대한민국
- 모병
- Seoul Metropolitan Government-Seoul National University Boramae Medical Center
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Ulsan, 대한민국
- 모병
- Ulsan University Hospital
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Busan
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Busan, Busan, 대한민국
- 모병
- Pusan National University Hospital
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Daegu
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Daegu, Daegu, 대한민국
- 모병
- Keimyung University Dongsan Hospital
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Gangwon-do
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Chuncheon, Gangwon-do, 대한민국
- 모병
- Kangwon National University Hospital
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Chuncheon, Gangwon-do, 대한민국
- 모병
- Hallym University Chuncheon Sacred Heart Hospital
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Gyeonggi-do
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Anyang-si, Gyeonggi-do, 대한민국
- 모병
- Hallym University Sacred Heart Hospital
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Jeollabuk-do
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Iksan, Jeollabuk-do, 대한민국
- 모병
- Wonkwang University Hospital
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Jeonju, Jeollabuk-do, 대한민국
- 모병
- Jeonbuk National University Hospital
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North Chungcheong
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Cheongju-si, North Chungcheong, 대한민국
- 모병
- Chungbuk National University Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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:
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Placebo
Placebo + Antiplatelet therapy
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Placebo drug + Antiplatelet therapy
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실험적: Tegoprazan
Tegoprazan 50mg daily + Antiplatelet therapy
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Tegoprazan 50mg daily + Antiplatelet therapy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Composite gastrointestinal complication
기간: 180 days
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Composite of upper or indeterminate origin gastrointestinal bleeding, gastric or duodenal ulcer ≥3 mm, or erosive esophagitis, ascertained up to a day-180 esophagogastroduodenoscopy
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180 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Upper GI bleeding
기간: 180 days
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overt upper GI bleeding confirmed by endoscopy or CT, overt upper GI bleeding of unknown source
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180 days
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GI bleeding of unknown upper/lower origin
기간: 180 days
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Hemoglobin fall ≥2 g/dL or hematocrit fall ≥10% presumed to be GI in origin without a likely hemorrhoidal, anal, or diverticular source.
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180 days
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Gastric ulcer
기간: 180 days
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Gastric ulcer ≥3 mm in diameter on esophagogastroduodenoscopy
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180 days
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Duodenal ulcer
기간: 180 days
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Duodenal ulcer ≥3 mm in diameter on esophagogastroduodenoscopy
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180 days
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Erosive esophagitis severity
기간: 180 days
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Erosive esophagitis severity by Los Angeles grade on esophagogastroduodenoscopy
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180 days
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Gastric mucosal injury
기간: 180 days
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Gastric mucosal injury by the modified Lanza score on esophagogastroduodenoscopy
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180 days
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Gastrointestinal Symptom Rating Scale score
기간: 180 days
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Change of Gastrointestinal Symptom Rating Scale (GSRS) score
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180 days
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Change of Reflux Disease Questionnaire (RDQ) score
기간: 180 days
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Change of Reflux Disease Questionnaire (RDQ) score
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180 days
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GI symptoms requiring medication
기간: 180 days
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occurrence of gastrointestinal symptoms requiring medication (e.g., chest pain, heartburn)
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180 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
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- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 1월 26일
기본 완료 (추정된)
2027년 6월 1일
연구 완료 (추정된)
2027년 12월 1일
연구 등록 날짜
최초 제출
2026년 6월 30일
QC 기준을 충족하는 최초 제출
2026년 6월 30일
처음 게시됨 (실제)
2026년 7월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 7일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TEGOSTROKE-P3-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .