Condition: Acute Coronary Syndrome · Helicobacter Pylori Infection · Sponsor: Qilu Hospital of Shandong University
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.
This description comes directly from the study's public registry record.
Yuan Bian, MD, PhD · +8618560083065 · bianyuan@sdu.edu.cn
Always discuss trial participation with your own doctor first.
| Bozhou People's Hospital | Bozhou, Anhui, China | Recruiting |
| Chuzhou First People's Hospital | Chuzhou, Anhui, China | Recruiting |
| The First Affiliated Hospital of Anhui Medical University | Hefei, Anhui, China | Not Yet Recruiting |
| Aviation General Hospital | Beijing, Beijing Municipality, China | Recruiting |
| China-Japan Friendship Hospital | Beijing, Beijing Municipality, China | Recruiting |
| The First People'S Hospital of Zunyi | Zunyi, Guizhou, China | Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou, Henan, China | Recruiting |
| The First Affiliated Hospital of Dalian Medical University | Dalian, Liaoning, China | Recruiting |
| Qinghai Red Cross Hospital | Xining, Qinghai, China | Recruiting |
| Qilu Hospital of Shandong University Dezhou Hospital | Dezhou, Shandong, China | Recruiting |
| Pingyuan First People'S Hospital | Dezhou, Shandong, China | Recruiting |
| NINGJIN People's Hospital | Dezhou, Shandong, China | Recruiting |
+ 30 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04728516