The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients
NCT ID: NCT04728516
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
2600 participants
INTERVENTIONAL
2023-04-12
2026-06-30
Brief Summary
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Detailed Description
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Antiplatelet drugs (DAPT) use aspirin 100 mg qd, plus clopidogrel 75 mg qd or aspirin 100mg qd plus ticagrelor 90 mg bid. The specific medication is evaluated and decided by the interventional doctor.
After the subjects in each center signed a written informed consent form, they randomly divided each test case into a test group or a control group at a 1:1 ratio:
1. Test group:
In the project participating hospitals who received coronary stenting and are expected to undergo DAPT ≥6 months after operation. Hp13C-urea breath test and serum Hp antibody scores Type detection, patients with positive Hp infection. Antiplatelet drugs (DAPT) use aspirin 100 mg qd, plus clopidogrel 75 mg qd or aspirin 100 mg qd, plus ticagrelor 90 mg bid. The specific medication is evaluated and decided by the interventional doctor.
H. 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 duration of 14 days(Considering the high drug resistance rate of Hp strains in China, we increase the course of eradication treatment to 14 days) .
i. Introduce the subject to the possible adverse reactions to the dual eradication at the informed stage, and inform the subject that when the adverse reaction occurs, the researcher should be contacted as soon as possible to deal with it as soon as possible to reduce unnecessary shedding. For patients who are unable to tolerate the combination therapy and fall off, record the reason for the incomplete treatment and the corresponding time point, and continue the safety visit.
ii. More than 1 month after completion of the dual eradication (scheduled at the 12th week of follow-up, visit 3), use the 13C-urea breath test to retest Hp infection. For subjects who failed H. pylori eradication, in the Department of Gastroenterology Remedial treatment under the guidance of a doctor.
2. Control group:
In the project participating hospitals who received coronary stenting and are expected to undergo DAPT ≥ 6 months after operation. Hp13C-urea breath test and serum Hp antibody scores Type detection, patients with positive Hp infection. Antiplatelet drugs (DAPT) use aspirin 100 mg qd, plus clopidogrel 75 mg qd or aspirin 100 mg qd plus ticagrelor 90 mg bid. The specific medication is evaluated and decided by the interventional doctor. Taking pantoprazole 40 mg daily, followed up to 6 months after randomization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Vonoprazan-based dual eradication therapy
H. 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 .
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
To take pantoprazole 40 mg daily, followed up to 6 months after randomization.
Pantoprazole
Pantoprazole
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Qilu Hospital of Shandong University
OTHER
Responsible Party
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Principal Investigators
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Yu-guo Chen, MD, PhD
Role: STUDY_CHAIR
Qilu Hospital of Shandong University
Locations
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Bozhou People's Hospital
Bozhou, Anhui, China
Chuzhou First People's Hospital
Chuzhou, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Aviation General Hospital
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
The First People'S Hospital of Zunyi
Zunyi, Guizhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Qinghai Red Cross Hospital
Xining, Qinghai, China
Qilu Hospital of Shandong University Dezhou Hospital
Dezhou, Shandong, China
Pingyuan First People'S Hospital
Dezhou, Shandong, China
NINGJIN People's Hospital
Dezhou, Shandong, China
Dongying People's Hospital
Dongying, Shandong, China
THE Second People's Hospital of Dongying
Dongying, Shandong, China
Heze Municipal Hospital
Heze, Shandong, China
The 960th Hospital of the Joint Logistic Support Force
Jinan, Shandong, China
Shandong Second Provincial General Hospital
Jinan, Shandong, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Third Hospital
Jinan, Shandong, China
The fourth People's Hospital of jinan
Jinan, Shandong, China
Shandong Public Health Clinical Center
Jinan, Shandong, China
JINA CITY People's Hospital
Jinan, Shandong, China
Central Hospital Affiliated to Shandong First medical University
Jinan, Shandong, China
The First People's Hospital of Jining City
Jining, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Linyi City People's Hospital
Linyi, Shandong, China
Linshu County People'S Hospital
Linyi, Shandong, China
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Affiliated Hospital of Shandong Second Medical University
Weifang, Shandong, China
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, China
Weihai Central Hospital
Weihai, Shandong, China
Weihai Municipal Hospital
Weihai, Shandong, China
Haiyang People's Hospital
Yantai, Shandong, China
Shandong Healthcare Group Zaozhuang Central Hospital
Zaozhuang, Shandong, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China
Zibo Central Hospital
Zibo, Shandong, China
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Ru Shan People's Hospital
Rushan, Yantai, China
Countries
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Central Contacts
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Facility Contacts
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Duoxue Chen
Role: primary
Tongtong Shen
Role: primary
xianhe lin
Role: primary
Yanfu Wang
Role: primary
Mingjing Shao
Role: primary
Xiaochuan Bai
Role: primary
Junhui Xing
Role: primary
Junjie Wang
Role: primary
Jiuping Zhao
Role: primary
Hongwei Dong
Role: primary
Xia Li
Role: primary
Tao Zhang
Role: primary
Xiaotian Wang
Role: primary
Tianjin Gu
Role: primary
Ke Liang
Role: primary
Zhen Wang
Role: primary
YUGUO CHEN
Role: primary
Guo Zhou
Role: primary
Qiang Liu
Role: primary
Xiaojuan Zhang
Role: primary
Zengtang Zhang
Role: primary
shuyin sun
Role: primary
yuzeng xue
Role: primary
yanjin wei
Role: primary
Xiaozhou Wang
Role: primary
beian you
Role: primary
Peng Li
Role: primary
Luchang Yin
Role: primary
Qinwei Zhu
Role: primary
xinfu zhou
Role: primary
Xuguang Liu
Role: primary
Jun Yang
Role: primary
changqian wang
Role: primary
Lei Dong
Role: primary
Other Identifiers
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2020SDUCRCA006
Identifier Type: -
Identifier Source: org_study_id
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