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

Who is this study for? Patients with Acute Coronary Syndrome, Helicobacter Pylori Infection
Status: Recruiting
Location: See all (42) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Aviation General Hospital
RECRUITING
Beijing
China-Japan Friendship Hospital
RECRUITING
Beijing
Bozhou People's Hospital
RECRUITING
Bozhou
Hospital of Chengdu University of Traditional Chinese Medicine
WITHDRAWN
Chengdu
Chuzhou First People's Hospital
RECRUITING
Chuzhou
The First Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
NINGJIN People's Hospital
RECRUITING
Dezhou
Pingyuan First People'S Hospital
RECRUITING
Dezhou
Qilu Hospital of Shandong University Dezhou Hospital
RECRUITING
Dezhou
Dongying People's Hospital
RECRUITING
Dongying
THE Second People's Hospital of Dongying
RECRUITING
Dongying
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
Heze Municipal Hospital
RECRUITING
Heze
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
RECRUITING
Jinan
Central Hospital Affiliated to Shandong First medical University
WITHDRAWN
Jinan
JINA CITY People's Hospital
RECRUITING
Jinan
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Shandong Provincial Third Hospital
RECRUITING
Jinan
Shandong Public Health Clinical Center
RECRUITING
Jinan
Shandong Second Provincial General Hospital
WITHDRAWN
Jinan
The 960th Hospital of the Joint Logistic Support Force
WITHDRAWN
Jinan
The fourth People's Hospital of jinan
RECRUITING
Jinan
The First People's Hospital of Jining City
NOT_YET_RECRUITING
Jining
Liaocheng People's Hospital
NOT_YET_RECRUITING
Liaocheng
Linshu County People'S Hospital
RECRUITING
Linyi
Linyi City People's Hospital
NOT_YET_RECRUITING
Linyi
Qilu Hospital of Shandong University (Qingdao)
NOT_YET_RECRUITING
Qingdao
The Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Ru Shan People's Hospital
RECRUITING
Rushan
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Tianjin Chest Hospital
WITHDRAWN
Tianjin
Affiliated Hospital of Shandong Second Medical University
RECRUITING
Weifang
Weifang Hospital of Traditional Chinese Medicine
RECRUITING
Weifang
Weihai Central Hospital
WITHDRAWN
Weihai
Weihai Municipal Hospital
NOT_YET_RECRUITING
Weihai
Qinghai Red Cross Hospital
RECRUITING
Xining
Haiyang People's Hospital
RECRUITING
Yantai
Shandong Healthcare Group Zaozhuang Central Hospital
WITHDRAWN
Zaozhuang
Zaozhuang Municipal Hospital
RECRUITING
Zaozhuang
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Zibo Central Hospital
WITHDRAWN
Zibo
The First People'S Hospital of Zunyi
RECRUITING
Zunyi
Contact Information
Primary
Yuan Bian, MD, PhD
bianyuan@sdu.edu.cn
+8618560083065
Time Frame
Start Date: 2023-04-12
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 2600
Treatments
Experimental: 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 .
Active_comparator: Pantoprazole
To take pantoprazole 40 mg daily, followed up to 6 months after randomization.
Sponsors
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov

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