Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent

Study Overview
=================
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®)

Official Title
-----------------
Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: P2Y12 antagonist monotherapy
* Drug: Aspirin plus P2Y12 antagonist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19+ Patients treated with a new generation of Evelorimus-eluting stents (Synergy®) Patients who understand the content of the subject description and voluntarily sign the subject Exclusion Criteria: Age 86+ Hemodynamically unstable patient Severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent Patients at high risk of bleeding, anemia, thrombocytopenia Patients requiring oral anticoagulants Pregnant women or women of childbearing age Life expectancy is less than one year Patients receiving a potent CYP3A4 inhibitor (eg, ketoconazole, clarithromycin, napjodone, ritonavir, atazanavir) Patients with a history of intracranial hemorrhage Patients with moderate to severe hepatic impairment Patients underwent coronary intervention with stenting within 1 year Patients with left-main lesions requiring coronary intervention Patients with chronic stricture lesions requiring treatment Patients with in-stent restenosis in a lesion requiring treatment Patients with bifurcation lesions requiring stenting in lateral branches Patients with lesions requiring more than 3 stents

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P2Y12 antagonist monotherapy<br>P2Y12 antagonist monotherapy after 3-month DAPT | Drug: P2Y12 antagonist monotherapy<br>* 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)<br>|
| Active Comparator: Aspirin + P2Y12 antagonist<br>Aspirin + P2Y12 antagonist after 3-month DAPT | Drug: Aspirin plus P2Y12 antagonist<br>* DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day) for a year<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular clinical events (MACCE) | cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization | between 3 and 12 month after the procedure | 
| Major bleeding | The Bleeding Academic Research Consortium (BARC) type 3 or 5 | between 3 and 12 month after the procedure |