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Dual H. pylori eradication versus proton pump inhibitor to prevent gastrointestinal bleeding in heart-attack patients on dual antiplatelet therapy

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

Phase 4 Interventional Qilu Hospital of Shandong University · NCT04728516

This trial tests whether a two-week vonoprazan-plus-amoxicillin H. pylori eradication regimen lowers gastrointestinal bleeding compared with standard PPI use in adults with acute coronary syndrome who are H. pylori–positive and on dual antiplatelet therapy after stenting.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment2600 (estimated)
Ages18 Years and up
SexAll
SponsorQilu Hospital of Shandong University Academic / other
Locations42 sites (Bozhou, Anhui and 41 other locations)
Trial IDNCT04728516 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, randomized Phase 4 trial will enroll 2,600 adults with ACS who underwent PCI, have confirmed H. pylori infection, and are expected to remain on DAPT for at least six months. Participants are randomized 1:1 to a 14-day vonoprazan 20 mg twice daily plus amoxicillin 1 g three times daily eradication regimen or usual care with a proton pump inhibitor, with antiplatelet choice (clopidogrel or ticagrelor) determined by the treating interventional cardiologist. The study follows patients for six months to compare rates of gastrointestinal bleeding and other safety outcomes. The trial aims to see if short-course eradication can reduce bleeding events and decrease reliance on long-term PPI in this high-bleeding-risk group.

Who should consider this trial

Good fit: Adults (≥18) with acute coronary syndrome who received coronary stenting, are H. pylori–positive, and are expected to continue DAPT for at least six months are ideal candidates.

Not a fit: Patients with prior gastrointestinal ulcer bleeding, current anticoagulant therapy, recent fibrinolysis, gastrectomy, severe liver or kidney dysfunction, or long-term PPI/H2 blocker use are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce gastrointestinal bleeding and lessen the need for long-term PPI therapy in H. pylori–positive patients on dual antiplatelet therapy.

How similar studies have performed: Prior studies indicate H. pylori eradication can reduce upper GI bleeding in patients on antithrombotic therapy, but large randomized trials using vonoprazan-based dual therapy in post-PCI ACS populations are limited.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Bozhou, Anhui and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Coronary SyndromeHelicobacter Pylori Infection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.