None listed
Conditions
Interventions
Drug : Subjects who have successfully undergone percutaneous coronary intervention using the EluNIR stent and have provided informed consent will be randomized. After PCI, dual antiplatelet therapy (a
Sponsors
Sahmyook Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 19 years Patients with coronary artery disease who have successfully undergone PCI using the EluNIR stent There are no restrictions on the number of lesions or vessels requiring treatment, or the length of the lesions. Patients who voluntarily agree to participate in the study, provide written informed consent, and are willing and able to comply with follow-up visits and examination schedules
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women Presence of cardiogenic shock Any comorbid condition expected to reduce life expectancy to less than 12 months History or presence of clinically significant medical disorders such as psychiatric illness that may interfere with study participation or outcomes Known allergy to protocol-required medications (e.g., aspirin, clopidogrel) for which adequate preventive management is not possible Inability to continue study-required medications after PCI Patients with galactose intolerance, lactase deficiency, or glucose-galactose malabsorption Patients with moderate to severe hepatic impairment (e.g., Child-Pugh class B or C) Patients currently receiving or planning to receive oral anticoagulant therapy (including vitamin K antagonists or direct oral anticoagulants such as dabigatran, rivaroxaban, apixaban, or edoxaban), or other antiplatelet agents (e.g., cilostazol) Patients who are not expected to comply with 3-month DAPT or long-term single antiplatelet therapy Patients currently participating in another clinical trial. However, enrollment is permitted if, in the investigator’s judgment, participation in another study does not affect the evaluation of this trial. Registry studies may also be allowed during participation in this study. Any other condition that the investigator deems inappropriate for study participation or that may increase the risk related to trial procedures (e.g., high risk of ischemic events after stent implantation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac and Cerebrovascular Events (MACCE) or BARC (Bleeding Academic Research Consortium) bleeding type =3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac and Cerebrovascular Events (MACCE);BARC (Bleeding Academic Research Consortium) bleeding type =3 | — |
Countries
Korea, Republic of
Contacts
Public ContactHyung Oh Kim
Sahmyook Medical Center
Outcome results
None listed