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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Bozhou People's Hospital
  Bozhou, Anhui, China Recruiting
• Chuzhou First People's Hospital
  Chuzhou, Anhui, China Recruiting
• Aviation General Hospital
  Beijing, Beijing Municipality, China Recruiting
• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First People'S Hospital of Zunyi
  Zunyi, Guizhou, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Yuan Bian, MD, PhD
• Email: bianyuan@sdu.edu.cn
• Phone: +8618560083065

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Common femoral vein-to-artery diameter ratio to detect elevated LVEDP

  Researchers test whether the ratio of the common femoral vein to artery diameters, measured by ultrasound, can flag elevated LV end-diastolic pressure in patients having coronary angiography.

  Recruiting Burapha University · Chon Buri · NCT07866859

• Intrahospital flu vaccine for adults with high cardiovascular risk when admitted for ACS or heart failure

  This study tests whether offering a flu vaccine at the bedside during a hospital stay, along with counseling, increases vaccination rates for adults with acute coronary syndrome or heart failure who are at high cardiovascular risk.

  Recruiting at 2 sites University Hospital of Cologne · Cologne and 1 other locations · NCT07721649

• Fecal transplant to help eradicate stubborn Helicobacter pylori infection

  This study tests whether giving a fecal microbiota transplant can help people with Helicobacter pylori infection that has not responded to standard treatments.

  Recruiting Phase 4 Sichuan Provincial People's Hospital · Chengdu, Sichuan · NCT07704255

• Digital lifestyle platform after rehabilitation to support self-management

  A digital, patient-facing platform is being tested to see if people who recently finished inpatient rehabilitation will use it and benefit from personalized lifestyle guidance at home.

  Recruiting at 2 sites Insel Gruppe AG, University Hospital Bern · Bern, Canton of Bern and 1 other locations · NCT07597031

• Fecal-guided simplified vonoprazan plus clarithromycin first-line therapy for H. pylori

  We are testing whether a two-drug regimen of vonoprazan plus clarithromycin clears H. pylori in adults whose fecal PCR shows no clarithromycin resistance mutations.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07439445

• Bismuth-amoxicillin-vonoprazan triple therapy versus bismuth-based quadruple therapy for H. pylori infection

  This will test whether a 14-day bismuth-amoxicillin-vonoprazan triple therapy works better and is as safe as a 14-day bismuth-based quadruple therapy for adults with H. pylori infection.

  Recruiting Kaohsiung Medical University · Kaohsiung City · NCT07358130

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.