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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,524
Tegoprazan 50mg daily + Antiplatelet therapy
Placebo drug + Antiplatelet therapy
Pusan National University Hospital
Busan, Busan, South Korea
RECRUITINGKeimyung University Dongsan Hospital
Daegu, Daegu, South Korea
RECRUITINGHallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea
RECRUITINGKangwon National University Hospital
Chuncheon, Gangwon-do, South Korea
RECRUITINGHallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
RECRUITINGWonkwang University Hospital
Iksan, Jeollabuk-do, South Korea
RECRUITINGJeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
RECRUITINGChungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
RECRUITINGDong-A University Hospital
Busan, South Korea
RECRUITINGKyungpook National University Chilgok Hospital
Daegu, South Korea
RECRUITING...and 14 more locations
Composite gastrointestinal complication
Composite of upper or indeterminate origin gastrointestinal bleeding, gastric or duodenal ulcer ≥3 mm, or erosive esophagitis, ascertained up to a day-180 esophagogastroduodenoscopy
Time frame: 180 days
Upper GI bleeding
overt upper GI bleeding confirmed by endoscopy or CT, overt upper GI bleeding of unknown source
Time frame: 180 days
GI bleeding of unknown upper/lower origin
Hemoglobin fall ≥2 g/dL or hematocrit fall ≥10% presumed to be GI in origin without a likely hemorrhoidal, anal, or diverticular source.
Time frame: 180 days
Gastric ulcer
Gastric ulcer ≥3 mm in diameter on esophagogastroduodenoscopy
Time frame: 180 days
Duodenal ulcer
Duodenal ulcer ≥3 mm in diameter on esophagogastroduodenoscopy
Time frame: 180 days
Erosive esophagitis severity
Erosive esophagitis severity by Los Angeles grade on esophagogastroduodenoscopy
Time frame: 180 days
Gastric mucosal injury
Gastric mucosal injury by the modified Lanza score on esophagogastroduodenoscopy
Time frame: 180 days
Gastrointestinal Symptom Rating Scale score
Change of Gastrointestinal Symptom Rating Scale (GSRS) score
Time frame: 180 days
Change of Reflux Disease Questionnaire (RDQ) score
Change of Reflux Disease Questionnaire (RDQ) score
Time frame: 180 days
GI symptoms requiring medication
occurrence of gastrointestinal symptoms requiring medication (e.g., chest pain, heartburn)
Time frame: 180 days
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