Tegoprazan to prevent GI complications in ischemic stroke patients on antiplatelet therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in Korea to see if tegoprazan 50 mg reduces gastrointestinal complications in patients beginning antiplatelet therapy after acute ischemic stroke or TIA. Participants are adults 19 and older who have started antiplatelet therapy within four weeks of an ischemic event and will continue treatment for at least six months. The trial compares tegoprazan to placebo and plans to enroll at more than 20 centers. Key eligibility excludes recent gastrointestinal bleeding or peptic ulcer disease and requires informed consent. The study aims to provide guidance on gastroprotection in stroke care, where evidence is currently limited.

Why it matters

Who can join: the full rules

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:

Where it's running

• 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

Study contacts

• Study coordinator: Seong-Ho Koh, MD, PhD
• Email: ksh213@hanyang.ac.kr
• Phone: +82-31-560-2267

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.