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
- Diseases
- Coronary artery disease
- 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
Sites (42)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aviation General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Bozhou People's Hospital Coordinator of this site? Confirm its status | Bozhou | China | Recruiting |
| Hospital of Chengdu University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Chengdu | China | Withdrawn |
| Chuzhou First People's Hospital Coordinator of this site? Confirm its status | Chuzhou | China | Recruiting |
| The First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| Qilu Hospital of Shandong University Dezhou Hospital Coordinator of this site? Confirm its status | Dezhou | China | Recruiting |
| Pingyuan First People'S Hospital Coordinator of this site? Confirm its status | Dezhou | China | Recruiting |
| Ningjin People's Hospital Coordinator of this site? Confirm its status | Dezhou | China | Recruiting |
| Dongying People's Hospital Coordinator of this site? Confirm its status | Dongying | China | Recruiting |
| The Second People's Hospital of Dongying Coordinator of this site? Confirm its status | Dongying | China | Recruiting |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Heze Municipal Hospital Coordinator of this site? Confirm its status | Heze | China | Recruiting |
| Shandong Public Health Clinical Center Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Shandong Second Provincial General Hospital Coordinator of this site? Confirm its status | Jinan | China | Withdrawn |
| The 960th Hospital of the Joint Logistic Support Force Coordinator of this site? Confirm its status | Jinan | China | Withdrawn |
| The Fourth People's Hospital of Jinan Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| Central Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Withdrawn |
| Shandong Provincial Third Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| JINA CITY People's Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Affiliated Hospital of Shandong University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| The First People's Hospital of Jining City Coordinator of this site? Confirm its status | Jining | China | Not yet recruiting |
| Liaocheng People's Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Not yet recruiting |
| Linyi City People's Hospital Coordinator of this site? Confirm its status | Linyi | China | Not yet recruiting |
| Linshu County People'S Hospital Coordinator of this site? Confirm its status | Linyi | China | Recruiting |
| Qilu Hospital of Shandong University (Qingdao) Coordinator of this site? Confirm its status | Qingdao | China | Not yet recruiting |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Ru Shan People's Hospital Coordinator of this site? Confirm its status | Rushan | China | Recruiting |
| The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Tianjin Chest Hospital Coordinator of this site? Confirm its status | Tianjin | China | Withdrawn |
| Weifang Hospital of traditional Chinese Medicine Coordinator of this site? Confirm its status | Weifang | China | Recruiting |
| Affiliated Hospital of Shandong Second Medical University Coordinator of this site? Confirm its status | Weifang | China | Recruiting |
| Weihai Municipal Hospital Coordinator of this site? Confirm its status | Weihai | China | Not yet recruiting |
| Weihai Central Hospital Coordinator of this site? Confirm its status | Weihai | China | Withdrawn |
| Qinghai Red Cross Hospital Coordinator of this site? Confirm its status | Xining | China | Recruiting |
| Haiyang People's Hospital Coordinator of this site? Confirm its status | Yantai | China | Recruiting |
| Shandong Healthcare Group Zaozhuang Central Hospital Coordinator of this site? Confirm its status | Zaozhuang | China | Withdrawn |
| Zaozhuang Municipal Hospital Coordinator of this site? Confirm its status | Zaozhuang | China | Recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Zibo Central hospital Coordinator of this site? Confirm its status | Zibo | China | Withdrawn |
| The first people's hospital of Zunyi Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.