Overview

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:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Qilu Hospital of Shandong University
Treatments:
Amoxicillin
Pantoprazole
Criteria
Inclusion Criteria:

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

2. Hp infection is positive;

3. Age ≥18 years old;

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

Exclusion Criteria:

1. Previous history of gastrointestinal ulcer bleeding;

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

3. Complicated with gastroesophageal varices, or after gastrectomy;

4. Those who are taking anti-coagulation drugs such as vitamin K antagonists (warfarin)
and have bleeding tendency;

5. Recently received fibrinolytic therapy (using fibrin-specific drugs within 24 hours
before randomization, or using non-fibrin-specific drugs within 48 hours before
randomization);

6. Recently accepted (within 30 days before randomization) or planned to undergo coronary
artery bypass grafting (CABG);

7. Combining active bleeding or coagulation dysfunction (indicator);

8. In patients with liver and kidney disease, serum creatinine is greater than 150
μmol/L, alanine aminotransferase and aspartate aminotransferase increase ≥2 times from
the normal value;

9. Complicated with hemorrhagic stroke, intracranial tumor, arteriovenous malformation or
aneurysm;

10. Anemia (adult male hemoglobin less than 120 g/L or red blood cells less than 4×1012/L,
adult female hemoglobin less than 105 g/L or red blood cells less than 3.5×1012/L);

11. Systemic glucocorticoid application;

12. Have taken antibiotics and other drugs that affect the flora in the stomach within the
past month;

13. A history of allergy to aspirin, clopidogrel, ticagrelor, pantoprazole, penicillin and
other test drugs;

14. Pregnancy or breastfeeding women and subjects of childbearing age who do not want to
take contraceptive measures;

15. With malignant tumors and other diseases, the expected survival time is less than 1
year;

16. Patients who participated in clinical trials of other drugs or are participating in
clinical studies of other new drugs within 30 days before enrollment;

17. Complicated with mental illness or severe neurosis;

18. Can't express subjective discomfort symptoms;

19. The investigator decides that it is not suitable to participate in this research.