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NCT04728516RecruitingPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 16 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
2600 (estimated)
First submitted
20 Jan 2021
Start date
12 Apr 2023
Primary completion date
30 Jun 2026
Lead sponsor
Qilu Hospital of Shandong University
NCT number
NCT04728516

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 2600
  • From 12 Apr 2023 to the primary completion date, 30 Jun 2026
  • 42 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous history of gastrointestinal ulcer bleeding;
  • Long-term use of PPI and H2 receptor inhibitors in the past;
  • Those who are taking anti-coagulation drugs such as vitamin K antagonists (warfarin) ,factor X or factor II inhibitors;
  • Recently received fibrinolytic therapy (using fibrin-specific drugs within 24 hours before randomization, or using non-fibrin-specific drugs within 48 hours before randomization);
  • Recently accepted (within 30 days before randomization) or planned to undergo coronary artery bypass grafting (CABG);
  • Have taken antibiotics and other drugs that affect the flora in the stomach within the past month;
  • Patients who participated in clinical trials of other drugs or are participating in clinical studies of other new drugs within 30 days before enrollment;

Other illness

  • Combining active bleeding or coagulation dysfunction (indicator);
  • Complicated with hemorrhagic stroke, intracranial tumor, arteriovenous malformation or aneurysm;
  • A history of allergy to aspirin, clopidogrel, ticagrelor, pantoprazole, penicillin and other test drugs;
  • With malignant tumors and other diseases, the expected survival time is less than 1 year;
  • Complicated with mental illness or severe neurosis;

Lab values

  • 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;
  • 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);

Age

  • Pregnancy or breastfeeding women and subjects of childbearing age who do not want to take contraceptive measures;

Other

  • Complicated with gastroesophageal varices, or after gastrectomy;
  • Systemic glucocorticoid application;
  • Can't express subjective discomfort symptoms;
  • The investigator decides that it is not suitable to participate in this research.

Who the study is looking for

  • Patients with ACS and PCI treatment and postoperative DAPT ≥ 6 months;
  • Hp infection is positive;
  • Age ≥18 years old;
  • The patient himself or his authorized client signs the subject's consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (42)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aviation General Hospital
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BeijingChinaRecruiting
China-Japan Friendship Hospital
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BeijingChinaRecruiting
Bozhou People's Hospital
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BozhouChinaRecruiting
Hospital of Chengdu University of Traditional Chinese Medicine
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ChengduChinaWithdrawn
Chuzhou First People's Hospital
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ChuzhouChinaRecruiting
The First Affiliated Hospital of Dalian Medical University
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DalianChinaRecruiting
Qilu Hospital of Shandong University Dezhou Hospital
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DezhouChinaRecruiting
Pingyuan First People'S Hospital
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DezhouChinaRecruiting
Ningjin People's Hospital
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DezhouChinaRecruiting
Dongying People's Hospital
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DongyingChinaRecruiting
The Second People's Hospital of Dongying
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DongyingChinaRecruiting
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaNot yet recruiting
Heze Municipal Hospital
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HezeChinaRecruiting
Shandong Public Health Clinical Center
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JinanChinaRecruiting
Shandong Second Provincial General Hospital
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JinanChinaWithdrawn
The 960th Hospital of the Joint Logistic Support Force
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JinanChinaWithdrawn
The Fourth People's Hospital of Jinan
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JinanChinaRecruiting
Qilu Hospital of Shandong University
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JinanChinaNot yet recruiting
Central Hospital Affiliated to Shandong First Medical University
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JinanChinaWithdrawn
Shandong Provincial Third Hospital
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JinanChinaRecruiting
JINA CITY People's Hospital
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JinanChinaRecruiting
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
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JinanChinaRecruiting
The First People's Hospital of Jining City
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JiningChinaNot yet recruiting
Liaocheng People's Hospital
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LiaochengChinaNot yet recruiting
Linyi City People's Hospital
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LinyiChinaNot yet recruiting
Linshu County People'S Hospital
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LinyiChinaRecruiting
Qilu Hospital of Shandong University (Qingdao)
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QingdaoChinaNot yet recruiting
The Affiliated Hospital of Qingdao University
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QingdaoChinaRecruiting
Ru Shan People's Hospital
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RushanChinaRecruiting
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
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ShanghaiChinaNot yet recruiting
Tianjin Chest Hospital
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TianjinChinaWithdrawn
Weifang Hospital of traditional Chinese Medicine
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WeifangChinaRecruiting
Affiliated Hospital of Shandong Second Medical University
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WeifangChinaRecruiting
Weihai Municipal Hospital
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WeihaiChinaNot yet recruiting
Weihai Central Hospital
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WeihaiChinaWithdrawn
Qinghai Red Cross Hospital
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XiningChinaRecruiting
Haiyang People's Hospital
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YantaiChinaRecruiting
Shandong Healthcare Group Zaozhuang Central Hospital
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ZaozhuangChinaWithdrawn
Zaozhuang Municipal Hospital
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ZaozhuangChinaRecruiting
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaRecruiting
Zibo Central hospital
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ZiboChinaWithdrawn
The first people's hospital of Zunyi
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ZunyiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.