The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients
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
| Condition(s) | Acute Coronary Syndrome, Helicobacter Pylori Infection |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 i |
| Who can participate | 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) ,factor X or factor II inhibitors; 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 pl |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Qilu Hospital of Shandong University |
| Locations | Bozhou, Anhui, China; Chuzhou, Anhui, China; Hefei, Anhui, China; Beijing, Beijing Municipality, China; Beijing, Beijing Municipality, China; Zunyi, Guizhou, China (+36 more sites) |
| Start date | 2023-04-12 |
| NCT ID | NCT04728516 |
| Official listing | https://clinicaltrials.gov/study/NCT04728516 |