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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

Qualifiers

Patients with ACS and PCI treatment and postoperative DAPT ≥ 6 months;

Hp infection is positive;

Age ≥18 years old;

The patient himself or his authorized client signs the subject's consent.

Disqualifiers

Previous history of gastrointestinal ulcer bleeding;

Long-term use of PPI and H2 receptor inhibitors in the past;

Complicated with gastroesophageal varices, or after gastrectomy;

Those who are taking anti-coagulation drugs such as vitamin K antagonists (warfarin) ,factor X or factor II inhibitors;

Trial design

Treatments tested in this trial

  • Vonoprazan-based dual eradication therapy for two weeks
  • amoxicillin
  • Pantoprazole

Treatment groups

2,600 Participants
are divided into 2 treatment groups