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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,524
- 试验地点
- 24
- 主要终点
- Composite gastrointestinal complication
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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:
研究组 & 干预措施
Placebo
Placebo + Antiplatelet therapy
干预措施: Placebo (Drug)
Tegoprazan
Tegoprazan 50mg daily + Antiplatelet therapy
干预措施: Tegoprazan 50 mg (Drug)
结局指标
主要结局
Composite gastrointestinal complication
时间窗: 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
次要结局
- Erosive esophagitis severity(180 days)
- Upper GI bleeding(180 days)
- GI bleeding of unknown upper/lower origin(180 days)
- Gastric ulcer(180 days)
- Duodenal ulcer(180 days)
- Gastric mucosal injury(180 days)
- Gastrointestinal Symptom Rating Scale score(180 days)
- Change of Reflux Disease Questionnaire (RDQ) score(180 days)
- GI symptoms requiring medication(180 days)
研究者
SEONG-HO KOH
Professor
Hanyang University Guri Hospital