Coronary Artery Disease
Conditions
Brief summary
To compare the clinical outcomes of P2Y12 antagonist monotherapy with aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with bioabsorbable polymer Everolimus-eluting stents (Synergy®)
Interventions
P2Y12 inhibitor(Clopidogrel 75mg/day or Ticagrelor 180mg/day) for 9months after 3 months of DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day)
DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day) for a year
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 19+ 2. Patients treated with a new generation of Evelorimus-eluting stents (Synergy®) 3. Patients who understand the content of the subject description and voluntarily sign the subject
Exclusion criteria
1. Age 86+ 2. Hemodynamically unstable patient 3. Severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent 4. Patients at high risk of bleeding, anemia, thrombocytopenia 5. Patients requiring oral anticoagulants 6. Pregnant women or women of childbearing age 7. Life expectancy is less than one year 8. Patients receiving a potent CYP3A4 inhibitor (eg, ketoconazole, clarithromycin, napjodone, ritonavir, atazanavir) 9. Patients with a history of intracranial hemorrhage 10. Patients with moderate to severe hepatic impairment 11. Patients underwent coronary intervention with stenting within 1 year 12. Patients with left-main lesions requiring coronary intervention 13. Patients with chronic stricture lesions requiring treatment 14. Patients with in-stent restenosis in a lesion requiring treatment 15. Patients with bifurcation lesions requiring stenting in lateral branches 16. Patients with lesions requiring more than 3 stents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular clinical events (MACCE) | between 3 and 12 month after the procedure | cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization |
| Major bleeding | between 3 and 12 month after the procedure | The Bleeding Academic Research Consortium (BARC) type 3 or 5 |
Countries
South Korea
Outcome results
None listed