The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients

NCT04728516 · tracked via the Priya Life Science China tracker

Sponsor

Qilu Hospital of Shandong University

Phase

Phase 4

Started

2023-04-12

Last updated

2025-09-16

Condition(s) studied

Acute Coronary SyndromeHelicobacter Pylori Infection

Investigational drug(s) / intervention(s)

Vonoprazan-based dual eradication therapy for two weeksamoxicillinPantoprazole

Vonoprazan-based dual eradication therapy for two weeks: Patients with ACS after PCI, associated with positive Hp need a long-term DAPT treatment. We conducted a study on the prevention of gastrointestinal bleeding between vonoprazan-based dual eradication therapy for two weeks and pantoprazole for six months of a rountine therapy.

amoxicillin: amoxicillin

Pantoprazole: Pantoprazole

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Gastrointestinal bleeding of 6 months in patients with ACS after PCI — 6 months
To compare the effects of the combination of vonoprazan + amoxicillin and pantoprazole on gastrointestinal bleeding events within 6 months in patients with ACS after PCI，The primary endpoint was gastrointestinal bleeding, including gastroduodenal bleeding, gastrointestinal bleeding with unknown bleeding site, and occult gastrointestinal bleeding.

Trial sites (42)

Facility	City	Region	Status
Bozhou People's Hospital	Bozhou	Anhui	Recruiting
Chuzhou First People's Hospital	Chuzhou	Anhui	Recruiting
The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	Not Yet Recruiting
Aviation General Hospital	Beijing	Beijing Municipality	Recruiting
China-Japan Friendship Hospital	Beijing	Beijing Municipality	Recruiting
The First People'S Hospital of Zunyi	Zunyi	Guizhou	Recruiting
The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	Recruiting
The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning	Recruiting
Qinghai Red Cross Hospital	Xining	Qinghai	Recruiting
Qilu Hospital of Shandong University Dezhou Hospital	Dezhou	Shandong	Recruiting
Pingyuan First People'S Hospital	Dezhou	Shandong	Recruiting
NINGJIN People's Hospital	Dezhou	Shandong	Recruiting
Dongying People's Hospital	Dongying	Shandong	Recruiting
THE Second People's Hospital of Dongying	Dongying	Shandong	Recruiting
Heze Municipal Hospital	Heze	Shandong	Recruiting
The 960th Hospital of the Joint Logistic Support Force	Jinan	Shandong	Withdrawn
Shandong Second Provincial General Hospital	Jinan	Shandong	Withdrawn
Affiliated Hospital of Shandong University of Traditional Chinese Medicine	Jinan	Shandong	Recruiting
Qilu Hospital of Shandong University	Jinan	Shandong	Not Yet Recruiting
Shandong Provincial Third Hospital	Jinan	Shandong	Recruiting
The fourth People's Hospital of jinan	Jinan	Shandong	Recruiting
Shandong Public Health Clinical Center	Jinan	Shandong	Recruiting
JINA CITY People's Hospital	Jinan	Shandong	Recruiting
Central Hospital Affiliated to Shandong First medical University	Jinan	Shandong	Withdrawn
The First People's Hospital of Jining City	Jining	Shandong	Not Yet Recruiting
Liaocheng People's Hospital	Liaocheng	Shandong	Not Yet Recruiting
Linyi City People's Hospital	Linyi	Shandong	Not Yet Recruiting
Linshu County People'S Hospital	Linyi	Shandong	Recruiting
Qilu Hospital of Shandong University (Qingdao)	Qingdao	Shandong	Not Yet Recruiting
The Affiliated Hospital of Qingdao University	Qingdao	Shandong	Recruiting
Affiliated Hospital of Shandong Second Medical University	Weifang	Shandong	Recruiting
Weifang Hospital of Traditional Chinese Medicine	Weifang	Shandong	Recruiting
Weihai Central Hospital	Weihai	Shandong	Withdrawn
Weihai Municipal Hospital	Weihai	Shandong	Not Yet Recruiting
Haiyang People's Hospital	Yantai	Shandong	Recruiting
Shandong Healthcare Group Zaozhuang Central Hospital	Zaozhuang	Shandong	Withdrawn
Zaozhuang Municipal Hospital	Zaozhuang	Shandong	Recruiting
Zibo Central Hospital	Zibo	Shandong	Withdrawn
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai Municipality	Not Yet Recruiting
Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan	Withdrawn

+ 2 more sites — see the full list on the official registry below.

On this site

📄 Amoxil (amoxicillin) drug profile → 📄 Protonix (pantoprazole) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04728516 on ClinicalTrials.gov ↗ ← All trials in China