Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy After DES

Study Overview
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Brief Summary
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To compare the efficacy and safety of clopidogrel monotherapy versus aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with DES.

Detailed Description
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This trial is a prospective, randomized, multi-center, open label, noninferiority trial. Patients undergoing PCI with DES will be eligible. After successful PCI with DES, all eligible patients will be randomized either to clopidogrel monotherapy or to aspirin plus P2Y12 antagonist following 3-month of DAPT.

Official Title
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Comparison Between P2Y12 Antagonist MonotHerapy and Dual Antiplatelet Therapy in Patients UndergOing Implantation of Coronary Drug-Eluting Stents

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: P2Y12 antagonist monotherapy
* Drug: aspirin plus P2Y12 antagonist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be at least 20 years of age. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. Patients undergoing successful PCI Exclusion Criteria: Hemodynamic instability or cardiogenic shock Active bleeding Known hypersensitivity or contraindication to study medications Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment). DES implantation within 12 months before index procedure

Ages Eligible for Study
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Minimum Age: 18 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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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> <br> |
| Experimental: Aspirin + P2Y12 antagonist<br>Aspirin + P2Y12 antagonist after 3-month DAPT | Drug: aspirin plus P2Y12 antagonist<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite of death, myocardial infarction, or cerebrovascular events | 12 months after the index procedure | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause Death |  | 1 years | 
| cardiac death |  | 1 years | 
| Myocardial infarction (MI) |  | 1 years | 
| Cerebrovascular accident (CVA) |  | 1 years | 
| Target lesion revascularization (TLR) |  | 1 years | 
| Target vessel revascularization (TVR) |  | 1 years | 
| Any revascularization |  | 1 years | 
| Stent thrombosis: definite or probable stent thrombosis by ARC definition |  | 1 years | 
| BARC bleeding ≥2 |  | 1 years | 
| BARC bleeding ≥3 |  | 1 years | 
| Major adverse cardiocerebral event (MACCE): death, MI, CVA, or any revascularization |  | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting stents, aspirin, P2Y12 antagonist monotherapy