NCT04728516

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

The Effect of Vonoprazan-based Dual Eradication Therapy vs PPI Treatment on Gastrointestinal Bleeding in ACS Patients With Hp Infection and Coronary Stents: an Open-label, Randomized, Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,600 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study plans to enroll 2600 patients, 1300 patients in each group, in the project participating hospitals who received coronary stenting and are expected to undergo DAPT ≥6 months after operation. Hp13C-urea breath test and serum Hp antibody scores Type detection, patients with positive Hp infection. Antiplatelet drugs (DAPT) use aspirin 100 mg qd, plus clopidogrel 75 mg qd or aspirin 100mg qd plus ticagrelor 90 mg bid. The specific medication is evaluated and decided by the interventional doctor. After the subjects in each center signed a written informed consent form, they randomly divided each test case into a test group or a control group at a 1:1 ratio: 1. Test group: In the project participating hospitals who received coronary stenting and are expected to undergo DAPT ≥6 months after operation. Hp13C-urea breath test and serum Hp antibody scores Type detection, patients with positive Hp infection. Antiplatelet drugs (DAPT) use aspirin 100 mg qd, plus clopidogrel 75 mg qd or aspirin 100 mg qd, plus ticagrelor 90 mg bid. The specific medication is evaluated and decided by the interventional doctor. H. pylori eradication using a dual eradication regimen, a course of 14 days, followed up to 6 months after randomization; the treatment regimen is as follows: routine use of Vonoprazan 20mg bid + amoxicillin 1g tid, a duration of 14 days(Considering the high drug resistance rate of Hp strains in China, we increase the course of eradication treatment to 14 days) . i. Introduce the subject to the possible adverse reactions to the dual eradication at the informed stage, and inform the subject that when the adverse reaction occurs, the researcher should be contacted as soon as possible to deal with it as soon as possible to reduce unnecessary shedding. For patients who are unable to tolerate the combination therapy and fall off, record the reason for the incomplete treatment and the corresponding time point, and continue the safety visit. ii. More than 1 month after completion of the dual eradication (scheduled at the 12th week of follow-up, visit 3), use the 13C-urea breath test to retest Hp infection. For subjects who failed H. pylori eradication, in the Department of Gastroenterology Remedial treatment under the guidance of a doctor. 2. Control group: In the project participating hospitals who received coronary stenting and are expected to undergo DAPT ≥ 6 months after operation. Hp13C-urea breath test and serum Hp antibody scores Type detection, patients with positive Hp infection. Antiplatelet drugs (DAPT) use aspirin 100 mg qd, plus clopidogrel 75 mg qd or aspirin 100 mg qd plus ticagrelor 90 mg bid. The specific medication is evaluated and decided by the interventional doctor. Taking pantoprazole 40 mg daily, followed up to 6 months after randomization.

Conditions

• Acute Coronary Syndrome
• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Vonoprazan-based dual eradication therapy for two weeks	Patients with ACS after PCI, associated with positive Hp need a long-term DAPT treatment. We conducted a study on the prevention of gastrointestinal bleeding between vonoprazan-based dual eradication therapy for two weeks and pantoprazole for six months of a rountine therapy.
DRUG	amoxicillin	amoxicillin
DRUG	Pantoprazole	Pantoprazole

Timeline

• Start date: 2023-04-12
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2021-01-28
• Last updated: 2025-09-16

Locations

42 sites across 1 country: China