BridgeMD
Prevention study for Ischemic Stroke
Official title Tegoprazan for Prevention of Gastrointestinal Complication in Ischemic Stroke Patients on Antiplatelet Therapy (TegoStroke)
ClinicalTrials.gov ID: NCT07687706
What this study is testing
What is Tegoprazan 50 mg?
Tegoprazan 50 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join 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...
- 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 likely can't join if
- History of peptic ulcer disease diagnosis or gastrointestinal bleeding within the past year. At screening, the history and findings of any EGD...
- Need for concomitant anticoagulant therapy (transient anticoagulation such as argatroban during the index admission is permitted, with randomization...
- 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...
- 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.
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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 how well it works or safety assessments of the present study; (2) a study involving an investigational product or...
- 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:
The study team makes the final eligibility decision.
Where it's taking place
- Busan, Busan, South Korea
- Daegu, Daegu, South Korea
- Chuncheon, Gangwon-do, South Korea
- Anyang-si, Gyeonggi-do, South Korea
- Iksan, Jeollabuk-do, South Korea
- Jeonju, Jeollabuk-do, South Korea
- Cheongju-si, North Chungcheong, South Korea
- Busan, South Korea
- Daegu, South Korea
- Guri-si, South Korea
- Gwangju, South Korea
- Seoul, South Korea
- Ulsan, South Korea
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Busan, Busan, South Korea; Daegu, Daegu, South Korea; Chuncheon, Gangwon-do, South Korea; Anyang-si, Gyeonggi-do, South Korea; Iksan, Jeollabuk-do, South Korea; Jeonju, Jeollabuk-do, South Korea and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.