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

Recruiting now · Phase 4

Conditions studied: Acute Coronary Syndrome, Helicobacter Pylori Infection

In brief

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.

Key facts

Study ID

NCT04728516

Run by

Qilu Hospital of Shandong University

People needed

2600

Starts

2023-04-12

Expected to finish

2026-06-30

Last updated by the study team

2025-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Previous history of gastrointestinal ulcer bleeding;
• Long-term use of PPI and H2 receptor inhibitors in the past;
• Complicated with gastroesophageal varices, or after gastrectomy;
• 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);
• Combining active bleeding or coagulation dysfunction (indicator);
• 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;
• Complicated with hemorrhagic stroke, intracranial tumor, arteriovenous malformation or aneurysm;
• 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);
• Systemic glucocorticoid application;
• Have taken antibiotics and other drugs that affect the flora in the stomach within the past month;
• A history of allergy to aspirin, clopidogrel, ticagrelor, pantoprazole, penicillin and other test drugs;
• Pregnancy or breastfeeding women and subjects of childbearing age who do not want to take contraceptive measures;
• With malignant tumors and other diseases, the expected survival time is less than 1 year;
• Patients who participated in clinical trials of other drugs or are participating in clinical studies of other new drugs within 30 days before enrollment;
• Complicated with mental illness or severe neurosis;
• Can't express subjective discomfort symptoms;
• The investigator decides that it is not suitable to participate in this research.

Where it is running

• Pingyuan First People'S Hospital — Dezhou, Shandong, China (enrolling)
• Chuzhou First People's Hospital — Chuzhou, Anhui, China (enrolling)
• NINGJIN People's Hospital — Dezhou, Shandong, China (enrolling)
• Dongying People's Hospital — Dongying, Shandong, China (enrolling)
• THE Second People's Hospital of Dongying — Dongying, Shandong, China (enrolling)
• Heze Municipal Hospital — Heze, Shandong, China (enrolling)
• Affiliated Hospital of Shandong University of Traditional Chinese Medicine — Jinan, Shandong, China (enrolling)
• Shandong Provincial Third Hospital — Jinan, Shandong, China (enrolling)
• The fourth People's Hospital of jinan — Jinan, Shandong, China (enrolling)
• Shandong Public Health Clinical Center — Jinan, Shandong, China (enrolling)
• JINA CITY People's Hospital — Jinan, Shandong, China (enrolling)
• Linshu County People'S Hospital — Linyi, Shandong, China (enrolling)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (enrolling)
• Affiliated Hospital of Shandong Second Medical University — Weifang, Shandong, China (enrolling)
• Weifang Hospital of Traditional Chinese Medicine — Weifang, Shandong, China (enrolling)
• Haiyang People's Hospital — Yantai, Shandong, China (enrolling)
• Zaozhuang Municipal Hospital — Zaozhuang, Shandong, China (enrolling)
• Ru Shan People's Hospital — Rushan, Yantai, China (enrolling)
• Aviation General Hospital — Beijing, Beijing Municipality, China (enrolling)
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First People'S Hospital of Zunyi — Zunyi, Guizhou, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (enrolling)
• Qinghai Red Cross Hospital — Xining, Qinghai, China (enrolling)
• Qilu Hospital of Shandong University Dezhou Hospital — Dezhou, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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