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

StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated September 16, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 6 more changesShow less
    • Primary completion date: Jan 30, 2023 to Jun 30, 2026
    • Start date changed from estimate of Aug 10, 2021 to Apr 12, 2023
    • Study sites: 10 to 42
    • Study completion date: Jun 30, 2023 to Jun 30, 2026
    • Secondary endpoints expanded, about 10 words
    • Eligibility criteria expanded, about 3 words
  2. Start date: Jul 16, 2021 to Aug 10, 2021v3
  3. Start date: Feb 1, 2021 to Jul 16, 2021
    • Study sites: 0 to 10
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04728516
Lead Sponsor Qilu Hospital of Shandong University
Conditions
(from sponsor)		 Acute Coronary Syndrome, Helicobacter Pylori Infection
Related terms Acute Coronary Syndrome
Enrollment 2,600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov