Actively Recruiting
The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients
Led by Qilu Hospital of Shandong University · Updated on 2025-09-16
2600
Participants Needed
42
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with acute coronary syndrome and PCI treatment with postoperative dual antiplatelet therapy for 6 months or more
- Positive Helicobacter pylori infection
- Age 18 years or older
- Patient or authorized representative signs informed consent
You will not qualify if you...
- Previous history of gastrointestinal ulcer bleeding
- Long-term use of proton pump inhibitors or H2 receptor inhibitors in the past
- Presence of gastroesophageal varices or history of gastrectomy
- Use of anticoagulant drugs such as warfarin or factor X/II inhibitors
- Recent fibrinolytic therapy before randomization
- Recent or planned coronary artery bypass grafting within 30 days
- Active bleeding or coagulation dysfunction
- Liver or kidney disease with specific abnormal laboratory values
- History of hemorrhagic stroke, intracranial tumor, arteriovenous malformation, or aneurysm
- Anemia below specified hemoglobin or red blood cell thresholds
- Systemic glucocorticoid use
- Antibiotic or flora-affecting drug use within the past month
- Known allergy to aspirin, clopidogrel, ticagrelor, pantoprazole, penicillin, or study drugs
- Pregnancy, breastfeeding, or unwillingness to use contraception if of childbearing potential
- Malignant tumors or expected survival less than 1 year
- Participation in other drug clinical trials within 30 days
- Mental illness or severe neurosis
- Inability to express subjective symptoms
- Investigator's judgment of unsuitability for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
Bozhou People's Hospital
Bozhou, Anhui, China, 236800
Actively Recruiting
2
Chuzhou First People's Hospital
Chuzhou, Anhui, China, 239000
Actively Recruiting
3
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
Not Yet Recruiting
4
Aviation General Hospital
Beijing, Beijing Municipality, China, 100012
Actively Recruiting
5
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
6
The First People'S Hospital of Zunyi
Zunyi, Guizhou, China, 563000
Actively Recruiting
7
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
8
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Actively Recruiting
9
Qinghai Red Cross Hospital
Xining, Qinghai, China, 810000
Actively Recruiting
10
Qilu Hospital of Shandong University Dezhou Hospital
Dezhou, Shandong, China, 253000
Actively Recruiting
11
Pingyuan First People'S Hospital
Dezhou, Shandong, China, 253100
Actively Recruiting
12
NINGJIN People's Hospital
Dezhou, Shandong, China, 253400
Actively Recruiting
13
Dongying People's Hospital
Dongying, Shandong, China, 257091
Actively Recruiting
14
THE Second People's Hospital of Dongying
Dongying, Shandong, China, 257335
Actively Recruiting
15
Heze Municipal Hospital
Heze, Shandong, China, 274031
Actively Recruiting
16
The 960th Hospital of the Joint Logistic Support Force
Jinan, Shandong, China, 250000
Withdrawn
17
Shandong Second Provincial General Hospital
Jinan, Shandong, China, 250002
Withdrawn
18
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China, 250011
Actively Recruiting
19
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
20
Shandong Provincial Third Hospital
Jinan, Shandong, China, 250031
Actively Recruiting
21
The fourth People's Hospital of jinan
Jinan, Shandong, China, 250031
Actively Recruiting
22
Shandong Public Health Clinical Center
Jinan, Shandong, China, 250100
Actively Recruiting
23
JINA CITY People's Hospital
Jinan, Shandong, China, 271199
Actively Recruiting
24
Central Hospital Affiliated to Shandong First medical University
Jinan, Shandong, China
Withdrawn
25
The First People's Hospital of Jining City
Jining, Shandong, China, 272000
Not Yet Recruiting
26
Liaocheng People's Hospital
Liaocheng, Shandong, China, 252000
Not Yet Recruiting
27
Linyi City People's Hospital
Linyi, Shandong, China, 276000
Not Yet Recruiting
28
Linshu County People'S Hospital
Linyi, Shandong, China, 276700
Actively Recruiting
29
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong, China, 266000
Not Yet Recruiting
30
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003
Actively Recruiting
31
Affiliated Hospital of Shandong Second Medical University
Weifang, Shandong, China, 261031
Actively Recruiting
32
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, China, 261041
Actively Recruiting
33
Weihai Central Hospital
Weihai, Shandong, China, 264200
Withdrawn
34
Weihai Municipal Hospital
Weihai, Shandong, China, 264200
Not Yet Recruiting
35
Haiyang People's Hospital
Yantai, Shandong, China, 256100
Actively Recruiting
36
Shandong Healthcare Group Zaozhuang Central Hospital
Zaozhuang, Shandong, China, 277000
Withdrawn
37
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China, 277100
Actively Recruiting
38
Zibo Central Hospital
Zibo, Shandong, China, 255000
Withdrawn
39
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
40
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China, 610072
Withdrawn
41
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China, 300222
Withdrawn
42
Ru Shan People's Hospital
Rushan, Yantai, China, 264500
Actively Recruiting
Research Team
Y
Yuan Bian, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here