Gastrointestinal Bleeding
Conditions
Interventions
Treatment group:Vonoprazan-based dual anti-H. pylori medication intervention for preventing DAPT-related gastrointestinal bleeding
Control group:PPI-based prevention of gastrointestinal bleeding caused by DAPT
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients with ACS undergoing PCI treatment and an expected postoperative duration of dual antiplatelet therapy (DAPT) of >= 6 months; 2.Positive for H. pylori infection; 3.Age >= 18 years old; 4.The patient themselves or their authorized representative signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Previous history of gastrointestinal ulcer bleeding; 2.Previous long-term use of PPI (proton pump inhibitors) and H2 receptor antagonists; 3.Complicated with gastric esophageal varices or post-gastrectomy; 4.Taking anticoagulant medications such as vitamin K antagonists (warfarin) and having a tendency to bleed; 5.Received fibrinolytic therapy recently (administration of fibrin-specific drugs within 24 hours prior to randomization or administration of non-fibrin-specific drugs within 48 hours prior to randomization); 6.Recently underwent (within 30 days prior to randomization) or planned to undergo coronary artery bypass grafting surgery (CABG); 7.Complicated with active bleeding or coagulation dysfunction (indicated by specific markers); 8.Patients with concurrent liver and kidney dysfunction, serum creatinine greater than 150 µmol/L, aspartate transaminase and alanine transaminase levels elevated more than twice the normal values; 9.Complicated with hemorrhagic stroke, intracranial tumor, arteriovenous malformation, or aneurysm; 10.Anemia (hemoglobin less than 120 g/L or red blood cells less than 4×10^12/L in adult males, hemoglobin less than 105 g/L or red blood cells less than 3.5×10^12/L in adult females); 11.Systemic corticosteroid administration; 12.Taken antibiotics or other medications that affect the gastric microbiota in the past month; 13.History of allergies to aspirin, clopidogrel, ticagrelor, pantoprazole, penicillin, and other investigational medications; 14.Pregnant or lactating women and reproductive-age participants who are unwilling to use contraception measures; 15.Complicated with malignant tumors and other diseases, with an expected survival period of less than 1 year; 16.Patients who participated in other drug clinical trials or are currently participating in other new drug clinical studies within 30 days prior to enrollment; 17.Complicated with mental illness or severe neurological disorders; 18.Unable to express subjective discomfort symptoms; 19.The researcher determines that the participant is not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal bleeding;H. pylori eradication status; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular and cerebrovascular adverse events;Composite gastrointestinal event; | — |
Countries
China
Contacts
Public ContactYuguo Chen
Qilu Hospital of Shandong University
Outcome results
None listed