None listed
Conditions
Interventions
Drug, Medical Device : The intervention in this study consists of a 2×2 factorial design comparing the duration of proton pump inhibitor therapy and the type of coronary stent. All participants will r
Sponsors
Gachon University Gil Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 19 years or older 2. Patients with acute coronary syndrome, including unstable angina, NSTEMI(Non-ST-Segment Elevation Myocardial Infarction), or STEMI(ST-Segment Elevation Myocardial Infarction), who undergo percutaneous coronary intervention with stent implantation and are scheduled to receive 12 months of dual antiplatelet therapy with aspirin and clopidogrel 3. Patients who are able to understand the study and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Women of childbearing potential who are planning to become pregnant during the study period 2. Patients with an absolute contraindication to proton pump inhibitors, such as a history of severe allergic reactions or anaphylaxis 3. Patients requiring continuous anticoagulant therapy 4. Patients with active bleeding or an active peptic ulcer for which treatment has not been completed 5. Patients with gastric or esophageal varices due to liver cirrhosis 6. Patients with a life expectancy of less than 1 year 7. Patients with a clinical condition that, in the investigator’s judgment, makes participation in the study inappropriate or impossible 8. Patients requiring long-term gastroprotective therapy because continuous use of nonsteroidal anti-inflammatory drugs or systemic corticosteroids is unavoidable 9. Patients with a life expectancy of less than 1 year 10. Patients with a clinical condition that, in the investigator’s judgment, makes participation in the study inappropriate or impossible 11. Patients requiring long-term gastroprotective therapy because continuous use of nonsteroidal anti-inflammatory drugs or systemic corticosteroids is unavoidable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NACE(Net Adverse Clinical Events) at 12 months, defined as a composite of death, myocardial infarction, ischemia-driven revascularization, stroke, and BARC(Bleeding Academic Research Consortium) type =2 bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause death at 12 months;Cardiac death at 12 months;Myocardial infarction at 12 months;Ischemia-driven revascularization at 12 months;ARC-defined stent thrombosis at 12 months;BARC(Bleeding Academic Research Consortium) type 2 or greater bleeding at 12 months;Changes in upper gastrointestinal endoscopic findings from baseline to 12 months, including the occurrence or recurrence of gastric or duodenal ulcer, high-risk endoscopic bleeding findings, lesions requiring endoscopic hemostasis, occurrence or worsening of erosive lesions, and changes in the grade of reflux esophagitis.;Any bleeding at 12 months;Safety outcomes potentially related to long-term PPI(Proton Pump Inhibitor) use, including vitamin B12 deficiency, hospitalization due to enteritis, and C. difficile infection. | — |
Countries
Korea, Republic of
Contacts
Public ContactJeongme Lee
Gachon University Gil Medical Center
Outcome results
None listed