Comparing Vonoprazan-Based Dual Eradication Therapy and Pantoprazole for Preventing Gastrointestinal Bleeding in Acute Coronary Syndrome Patients with Helicobacter Pylori Infection After Coronary Stenting

What this Trial Is About

This research aims to evaluate the effect of two different treatments on gastrointestinal bleeding in patients with acute coronary syndrome ACS who have undergone percutaneous coronary intervention PCI and require dual antiplatelet therapy DAPT for at least six months. The study focuses on patients infected with Helicobacter pylori Hp, a known risk factor for gastrointestinal bleeding, which occurs commonly in these patients. Experts in China have recommended Hp detection and eradication therapy alongside DAPT, but evidence is lacking. This trial investigates whether Vonoprazan-based dual eradication therapy is not inferior to standard proton pump inhibitor PPI treatment in preventing bleeding events. The study enrolls 2600 patients randomized into two groups. One group receives a 14-day dual eradication therapy with Vonoprazan 20 mg twice daily and amoxicillin 1 g three times daily, followed by monitoring for six months. The other group receives pantoprazole 40 mg daily for six months as the control treatment. All patients continue their DAPT regimen, which includes aspirin and either clopidogrel or ticagrelor, as decided by their doctors. Hp infection is confirmed before enrollment using breath tests and antibody detection. Participants will be closely monitored throughout the six-month follow-up period. Assessments include repeat Hp testing after treatment completion and tracking any gastrointestinal bleeding or major cardiovascular events. Safety visits record any adverse reactions or incomplete treatments. The primary outcome measured is the incidence of gastrointestinal bleeding over six months, with additional outcomes including cardiovascular events and complex gastrointestinal events. This comprehensive monitoring aims to provide clear evidence on managing Hp infection in ACS patients undergoing DAPT.

The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients