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RECRUITING

NCT04728516

PHASE4

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

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2600

Start Date

2023-04-12

Completion Date

2026-06-30

Last Updated

2025-09-16

Healthy Volunteers

Conditions

Acute Coronary Syndrome Helicobacter Pylori Infection

Interventions

DRUG

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.

DRUG

amoxicillin

DRUG

Pantoprazole

Inclusion Criteria: 1. Patients with ACS and PCI treatment and postoperative DAPT ≥ 6 months; 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: 1. Previous history of gastrointestinal ulcer bleeding; 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.

Locations (42)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (42)