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
1 other identifier
interventional
2,600
1 country
42
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2023
Typical duration for phase_4
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2021
CompletedFirst Posted
Study publicly available on registry
January 28, 2021
CompletedStudy Start
First participant enrolled
April 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
September 16, 2025
September 1, 2025
3.2 years
January 20, 2021
September 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Gastrointestinal bleeding of 6 months in patients with ACS after PCI
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.
6 months
Secondary Outcomes (2)
major adverse cardiovascular and cerebrovascular events (MACCE)
6 month
complex gastrointestinal event
6month
Study Arms (2)
Vonoprazan-based dual eradication therapy
EXPERIMENTALH. pylori eradication using a dual eradication regimen, a course of 14 days, followed up to 6 months after randomization; the treatment regimen is as follows: routine use of Vonoprazan 20mg bid + amoxicillin 1g tid, a course of 14 days .
Pantoprazole
ACTIVE COMPARATORTo take pantoprazole 40 mg daily, followed up to 6 months after randomization.
Interventions
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.
Eligibility Criteria
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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Bozhou People's Hospital
Bozhou, Anhui, 236800, China
Chuzhou First People's Hospital
Chuzhou, Anhui, 239000, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
Aviation General Hospital
Beijing, Beijing Municipality, 100012, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
The First People'S Hospital of Zunyi
Zunyi, Guizhou, 563000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Qinghai Red Cross Hospital
Xining, Qinghai, 810000, China
Qilu Hospital of Shandong University Dezhou Hospital
Dezhou, Shandong, 253000, China
Pingyuan First People'S Hospital
Dezhou, Shandong, 253100, China
NINGJIN People's Hospital
Dezhou, Shandong, 253400, China
Dongying People's Hospital
Dongying, Shandong, 257091, China
THE Second People's Hospital of Dongying
Dongying, Shandong, 257335, China
Heze Municipal Hospital
Heze, Shandong, 274031, China
The 960th Hospital of the Joint Logistic Support Force
Jinan, Shandong, 250000, China
Shandong Second Provincial General Hospital
Jinan, Shandong, 250002, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250011, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Shandong Provincial Third Hospital
Jinan, Shandong, 250031, China
The fourth People's Hospital of jinan
Jinan, Shandong, 250031, China
Shandong Public Health Clinical Center
Jinan, Shandong, 250100, China
JINA CITY People's Hospital
Jinan, Shandong, 271199, China
Central Hospital Affiliated to Shandong First medical University
Jinan, Shandong, China
The First People's Hospital of Jining City
Jining, Shandong, 272000, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
Linyi City People's Hospital
Linyi, Shandong, 276000, China
Linshu County People'S Hospital
Linyi, Shandong, 276700, China
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong, 266000, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
Affiliated Hospital of Shandong Second Medical University
Weifang, Shandong, 261031, China
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, 261041, China
Weihai Central Hospital
Weihai, Shandong, 264200, China
Weihai Municipal Hospital
Weihai, Shandong, 264200, China
Haiyang People's Hospital
Yantai, Shandong, 256100, China
Shandong Healthcare Group Zaozhuang Central Hospital
Zaozhuang, Shandong, 277000, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, 277100, China
Zibo Central Hospital
Zibo, Shandong, 255000, China
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610072, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222, China
Ru Shan People's Hospital
Rushan, Yantai, 264500, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yu-guo Chen, MD, PhD
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2021
First Posted
January 28, 2021
Study Start
April 12, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
September 16, 2025
Record last verified: 2025-09