None listed
Conditions
Interventions
Drug : Subjects of the clinical trial who underwent EluNIR™ stent insertion for acute myocardial infarction will receive dual antiplatelet therapy for 3 months and then single antiplatelet therapy for
Sponsors
Chungbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 19 years or older 2. Patients with AMI (ST-Segment Elevation Myocardial Infarction [STEMI] or Non-ST-Segment Elevation Myocardial Infarction [NSTEMI]) who underwent PCI using EluNIR™ stent * AMI definition is based on the 3rd Universal Definition of Myocardial Infarction. 3. Patients who voluntarily decided to participate in this study, provided written informed consent, and were willing and able to comply with the schedule of follow-up visits and examinations
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women or women planning to become pregnant within 12 months after the procedure or who do not agree to use adequate contraception during the 12-month period 2. Cardiogenic shock 3. Patients with anemia (hemoglobin <10 g/Dl) or platelet count 100,000/mm3 4. Any co-morbid condition that may reduce life expectancy to less than 12 months (e.g., cancer, severe heart failure, severe pulmonary disease) 5. Previous or current medical illness (e.g., pneumonia, systemic infection, etc.) that causes clinically significant impairment of the cardiovascular, digestive, respiratory, endocrine, or central nervous systems or mental illness that significantly affects this clinical trial 6. Allergies to essential concomitant medications in the protocol, such as aspirin, Clopidogrel, Ticagrelor, heparin and bivalirudin or iodinated contrast media, for which appropriate prophylaxis is not available. 7. Patients who cannot continue taking the drugs required for the clinical trial after PCI • Patients with severe renal impairment (glomerular filtration rate less than 10 mL/min) • Patients with galactose intolerance, lactase deficiency, or glucose-galactose malabsorption • Patients with moderate or severe hepatic dysfunction (e.g., Child Pugh B or C) • Patients receiving strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir) • Patients receiving oral anticoagulant therapy (concurrent treatment with vitamin K antagonists or novel oral anticoagulants such as Dabigatran, Rivaroxaban, Apixaban, or Edoxaban) • Patients receiving daily treatment with nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors • Patients receiving daily NSAIDs (Nonsteroidal Anti-Inflammatory Drugs, 8. Patients who are not compliant with 3-month DAPT or are expected not to be compliant with long-term single antiplatelet therapy 9. Patients with a history of prior stent thrombosis 10. Patients who require planned staged PCI with a non-investigational stent 11. Patients receiving renal replacement therapy for renal failure or a history of kidney transplantation 12. Patients with symptoms of sinus bradycardia (sick sinus syndrome) or atrioventricular (AV) block (AV block grade II or III, Bradycardia-Induced Syncope; excluding patients with permanent pacemaker implantation) 13. Those who have experienced gastrointestinal or urological bleeding, hemoptysis, or vitreous hemorrhage within 2 months prior to the screening date 14. Currently participating in another clinical trial. However, even if they have participated in another clinical trial in the past, if it does not affect the evaluation of this clinical trial in the judgment of the investigator, they may be enrolled. 15. Others, if the investigator determines that the patient is not suitable for this clinical trial or may increase the risk associated with participation in the clinical trial Angiographic exclusion criteria 1. The reference vessel diameter is less than 2.5 mm 2. The lesion is located in the Left Main (LM) 3. Restenosis lesion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Endpoint of Major Adverse Cardiac and Cerebrovascular Events (MACCE: All-Cause Death, Myocardial Infarction [MI], Stent Thrombosis, or Stroke);BARC (Bleeding Academic Research Consortium) Bleeding Type 2, 3 or 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| MACCE, All-Cause Death, Target Lesion Failure, Target Vessel Failure, Stroke, BARC Bleeding Type 1, 2, 3 or 5 | — |
Countries
Korea, Republic of
Contacts
Public ContactChungsuk Lee
Chungbuk National University Hospital
Outcome results
None listed