Comparing Potassium Competitive Acid Blocker to Guideline-Based Gut Protection in Heart Attack Patients Undergoing Stent Procedures on Dual Antiplatelet Therapy

What this Trial Is About

Researchers are evaluating the clinical outcomes of two gastrointestinal protection strategies in patients with acute myocardial infarction AMI who are undergoing percutaneous coronary intervention PCI and receiving dual antiplatelet therapy DAPT. This phase 3, prospective, open-label, randomized trial aims to compare routine use of potassium competitive acid blocker P-CAB and guideline-directed gastrointestinal GI protection. The study will enroll 5,000 patients to better understand which approach may impact adverse events after AMI treatment. Participants will be randomly assigned to one of two groups one receiving daily oral Zastaprazan citrate 20 mg as routine P-CAB use, and the other receiving guideline-directed GI protection with proton pump inhibitors PPIs chosen by their physician. The trial is planned across multiple centers and will follow participants for one year to assess outcomes. The main outcome measured is the occurrence of Net Adverse Clinical Events NACE, which includes death, myocardial infarction, stroke, or serious bleeding. During the study, participants will be monitored for these clinical events and adherence to the assigned gastrointestinal protection strategy. Safety and health status will be evaluated throughout the one-year period following PCI and DAPT treatment. The study is sponsored by Samsung Medical Center and aims to provide important information on managing GI protection in AMI patients receiving dual antiplatelet therapy.

Routine Use of Potassium Competitive Acid Blocker vs. Guideline-Directed Gastrointestinal Protection Strategy in Acute Myocardial Infarction