Status:
RECRUITING
The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Acute Coronary Syndrome
Helicobacter Pylori Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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, gastro...
Detailed Description
This study plans to enroll 2600 patients, 1300 patients in each group, in the project participating hospitals who received coronary stenting and are expected to undergo DAPT ≥6 months after operation....
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Recently received fibrinolytic therapy (using fibrin-specific drugs within 24 hours before randomization, or using non-fibrin-specific drugs within 48 hours before randomization);
- Recently accepted (within 30 days before randomization) or planned to undergo coronary artery bypass grafting (CABG);
- Combining active bleeding or coagulation dysfunction (indicator);
- In patients with liver and kidney disease, serum creatinine is greater than 150 μmol/L, GFR \<60ml/min/1.73m2, alanine aminotransferase and aspartate aminotransferase increase ≥3 times from the normal value;
- Complicated with hemorrhagic stroke, intracranial tumor, arteriovenous malformation or aneurysm;
- Anemia (adult male hemoglobin less than 120 g/L or red blood cells less than 4×10\^12/L,adult female hemoglobin less than 105 g/L or red blood cells less than 3.5×10\^12/L);
- Systemic glucocorticoid application;
- Have taken antibiotics and other drugs that affect the flora in the stomach within the past month;
- A history of allergy to aspirin, clopidogrel, ticagrelor, pantoprazole, penicillin and other test drugs;
- Pregnancy or breastfeeding women and subjects of childbearing age who do not want to take contraceptive measures;
- With malignant tumors and other diseases, the expected survival time is less than 1 year;
- Patients who participated in clinical trials of other drugs or are participating in clinical studies of other new drugs within 30 days before enrollment;
- Complicated with mental illness or severe neurosis;
- Can't express subjective discomfort symptoms;
- The investigator decides that it is not suitable to participate in this research.
Key Trial Info
Start Date :
April 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
2600 Patients enrolled
Trial Details
Trial ID
NCT04728516
Start Date
April 12 2023
End Date
June 30 2026
Last Update
September 16 2025
Active Locations (42)
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1
Bozhou People's Hospital
Bozhou, Anhui, China, 236800
2
Chuzhou First People's Hospital
Chuzhou, Anhui, China, 239000
3
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
4
Aviation General Hospital
Beijing, Beijing Municipality, China, 100012