The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients
Status:
Not yet recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
Patients with acute coronary syndrome (ACS) after Percutaneous Coronary Intervention (PCI)
require routine treatment with dual antiplatelet (DAPT) treatment, but with the high risk of
bleeding, gastrointestinal bleeding is the most common type of major bleeding. Helicobacter
pylori (Hp) infection is a high-risk factor for gastrointestinal bleeding, with an incidence
of about 50%. Foreign authoritative DAPT guidelines do not give individual guidance to
Hp-infected patients. It is recommended that those with high bleeding risk should be combined
with proton pump inhibitors (PPI), but long-term compliance with PPI is not ideal.
Authoritative experts in China have agreed to recommend Hp detection and eradication therapy
for DAPT patients, but loss of evidence. Vonoprazan is a novel potassium ion competitive acid
blocker, based on Vonoprazan's dual Hp eradication therapy is simple and effective. Our team
will conduct a multi-center, open-label, randomized controlled clinical trial using a
non-inferior design to compare the combination of Vonoprazan + amoxicillin combined with
pantoprazole (PPI) for 6 months after PCI on the bleeding events of the digestive tract.