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Study identifier: NCT04728516 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Acute Coronary Syndrome · Helicobacter Pylori Infection  ·  Sponsor: Qilu Hospital of Shandong University

PhasePhase 4
Planned participants2600
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

Talk to the study team

Yuan Bian, MD, PhD  ·  +8618560083065  ·  bianyuan@sdu.edu.cn

Always discuss trial participation with your own doctor first.

Locations (42)

Bozhou People's HospitalBozhou, Anhui, ChinaRecruiting
Chuzhou First People's HospitalChuzhou, Anhui, ChinaRecruiting
The First Affiliated Hospital of Anhui Medical UniversityHefei, Anhui, ChinaNot Yet Recruiting
Aviation General HospitalBeijing, Beijing Municipality, ChinaRecruiting
China-Japan Friendship HospitalBeijing, Beijing Municipality, ChinaRecruiting
The First People'S Hospital of ZunyiZunyi, Guizhou, ChinaRecruiting
The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, Henan, ChinaRecruiting
The First Affiliated Hospital of Dalian Medical UniversityDalian, Liaoning, ChinaRecruiting
Qinghai Red Cross HospitalXining, Qinghai, ChinaRecruiting
Qilu Hospital of Shandong University Dezhou HospitalDezhou, Shandong, ChinaRecruiting
Pingyuan First People'S HospitalDezhou, Shandong, ChinaRecruiting
NINGJIN People's HospitalDezhou, Shandong, ChinaRecruiting

+ 30 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04728516