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Clinical Trials in Japan / NCT04728516
Recruiting Phase 4

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

NCT04728516 · tracked via the Priya Life Science Japan 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 weeksamoxicillin →Pantoprazole →

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
No
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)

FacilityCityRegionStatus
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 →

Other trials for the same condition

Thrombus Aspiration and Pathology and OCT Study Recruiting
Genotyping GUided Antiplatelet theRapy in pAtieNts Treated With Drug Eluting stEnts (GUARANTEE) Active, not recruiting
Guideline Oriented Approach To Lipid Lowering In Asia-Pacific Recruiting
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes Recruiting
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 Japan