3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation

Study Overview
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Brief Summary
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To evaluate safety of reduction of dual antiplatelet therapy period to three months after implantation of Ultimaster sirolimus-eluting stent (U-SES). Additionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin.

Official Title
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3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Aspirin
* Drug: Thienopyridine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with coronary artery lesion who received percutaneous coronary intervention using Ultimaster sirolimus-eluting stent. Patients considered appropriate to discontinue dual antiplatelet therapy at 3 months after stent implantation. Patients who have provided written informed consent. Exclusion Criteria: Patients previously experienced stent thrombosis. Patients who are unable to clinical follow-up procedure specified in the protocal for the present study. Patients who are enrolled or planned to participate in another clinical trials of antiplatelet therapy.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin<br>Aspirin treatment for 3 months after the Ultimaster sirolimus-eluting stent implantation. | Drug: Aspirin<br>* Discontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.<br>|
| Experimental: Thienopyridine<br>Thienopyridine treatment for 3 months after the Ultimaster sirolimus-eluting Stent implantation. | Drug: Thienopyridine<br>* Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of all cause death in 12 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5). |  | 12-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of all cause death in 3 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5). |  | 3-month | 
| Major adverse cardiac event |  | 3-month | 
| Major adverse cardiac event |  | 12-month | 
| All cause death |  | 3-month | 
| All cause death |  | 12-month | 
| Cardiac death |  | 3-month | 
| Cardiac death |  | 12-month | 
| Myocardial infarction |  | 3-month | 
| Myocardial infarction |  | 12-month | 
| Stroke (ischemic and hemorrhagic) |  | 3-month | 
| Stroke (ischemic and hemorrhagic) |  | 12-month | 
| Target lesion revascularization |  | 3-month | 
| Target lesion revascularization |  | 12-month | 
| Target vessel revascularization |  | 3-month | 
| Target vessel revascularization |  | 12-month | 
| Readmission related to angina |  | 3-month | 
| Readmission related to angina |  | 12-month | 
| Stent thrombosis |  | 3-month | 
| Stent thrombosis (ARC definition) |  | 12-month | 
| Bleeding complications (BARC definition) |  | 3-month | 
| Bleeding complications (BARC definition) |  | 12-month | 
| Comparison of event rate by the type of antiplatelet agent |  | 12-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-Eluting Stent