NCT04728516 The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients
| NCT ID | NCT04728516 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,600 participants |
| Start Date | 2023-04-12 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,600 participants in total. It began in 2023-04-12 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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) ,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 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, GFR \<60ml/min/1.73m2, alanine aminotransferase and aspartate aminotransferase increase ≥3 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 4×10\^12/L,adult female hemoglobin less than 105 g/L or red blood cells less than 3.5×10\^12/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.
Contact & Investigator
Yu-guo Chen, MD, PhD
STUDY CHAIR
Qilu Hospital of Shandong University
Frequently Asked Questions
Who can join the NCT04728516 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04728516 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04728516 currently recruiting?
Yes, NCT04728516 is actively recruiting participants. Contact the research team at bianyuan@sdu.edu.cn for enrollment information.
Where is the NCT04728516 trial being conducted?
This trial is being conducted at Bozhou, China, Chuzhou, China, Hefei, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT04728516 clinical trial?
NCT04728516 is sponsored by Qilu Hospital of Shandong University. The principal investigator is Yu-guo Chen, MD, PhD at Qilu Hospital of Shandong University. The trial plans to enroll 2,600 participants.