Phase 3 Study of Tegoprazan to Prevent Gastrointestinal Problems in Adults with Ischemic Stroke Taking Antiplatelet Therapy

What this Trial Is About

Researchers are evaluating whether tegoprazan, a potassium-competitive acid blocker, can reduce gastrointestinal complications in adults who have had an ischemic stroke or transient ischemic attack and are receiving antiplatelet therapy. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial is conducted at more than 20 centers in the Republic of Korea. It addresses the lack of evidence for gastroprotection in stroke care, despite known risks associated with antiplatelet therapy. Participants are randomly assigned to receive either oral tegoprazan 50 mg once daily or a matching placebo alongside their antiplatelet therapy for 180 days. The study compares the effects of tegoprazan versus placebo on preventing gastrointestinal bleeding, ulcers, and erosive esophagitis during this period. The primary outcome is a composite measure of these gastrointestinal complications assessed by esophagogastroduodenoscopy at 180 days. During the study, participants will undergo gastrointestinal evaluations and symptom assessments to monitor for complications. Researchers will track various outcomes including upper gastrointestinal bleeding, gastric and duodenal ulcers, esophagitis severity, mucosal injury, and gastrointestinal symptoms requiring medication. The trials total follow-up period is 180 days, with safety and efficacy monitored throughout the study.

Tegoprazan for Prevention of Gastrointestinal Complication in Ischemic Stroke Patients on Antiplatelet Therapy (TegoStroke)