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

ConditionsAcute Coronary SyndromeHelicobacter Pylori Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Previous history of gastrointestinal ulcer bleeding;

Long-term use of PPI and H2 receptor inhibitors in the past;

Complicated with gastroesophageal varices, or after gastrectomy;

Those who are taking anti-coagulation drugs such as vitamin K antagonists (warfarin) ,factor X or factor II inhibitors;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vonoprazan-based dual eradication therapy for two weeks

    Drug

    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.

  • amoxicillin

    Drug

    amoxicillin

  • Pantoprazole

    Drug

    Pantoprazole

Treatment groups

2,600 Participants
are divided into 2 treatment groups
Group A: Vonoprazan-based dual eradication therapyExperimental treatment 2 interventions
Group B: PantoprazoleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Gastrointestinal bleeding of 6 months in patients with ACS after PCI

To compare the effects of the combination of vonoprazan + amoxicillin and pantoprazole on gastrointestinal bleeding events within 6 months in patients with ACS after PCI，The primary endpoint was gastrointestinal bleeding, including gastroduodenal bleeding, gastrointestinal bleeding with unknown bleeding site, and occult gastrointestinal bleeding.

Time frame
6 months

Secondary outcomes

1

major adverse cardiovascular and cerebrovascular events (MACCE)

To compare the effects of the combination of vonoprazan + amoxicillin and pantoprazole on major adverse cardiovascular and cerebrovascular events (MACCE) within 6 months in patients with ACS after PCI. The secondary outcomes measure were MACCE , including :stent thrombosis, recurrent myocardial infarction, unplanned revascularization cardiogenic shock, stroke, cardiovascular death, and all-cause death.

Time frame
6 month
2

complex gastrointestinal event

To compare the effects of the combination of vonoprazan + amoxicillin and pantoprazole on complex gastrointestinal events. The secondary outcomes measure were complex gastrointestinal events, including upper gastrointestinal bleeding (BARC type), symptomatic gastroduodenal ulcer, gastroesophageal reflux, intestinal obstruction, gastrointestinal perforation, diarrhea, dyspepsia.

Time frame
6month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Hospital of Shandong University

Lead sponsor

Source ClinicalTrials.gov
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