Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin

Study Overview
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Brief Summary
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The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.

Official Title
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Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin in Korean Patients With Coronary Artery Disease (a Single-center, Randomized, Open-label Clinical Trial)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Closone
* Drug: Plavix with Astrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects under condition after Post-Percutaneous Coronary Artery Intervention over twelve months 20 85 years old Willing to adhere to protocol requirements and sign a informed consent form Exclusion Criteria: Subject who did not undergo or failed Stent Implantation Subjects who took an anti-coagulant, anti-thrombotic regularly before the study, or plan to have continuous treatment during the study Subjects with a history of hypersensitivity to Clopidogrel, Aspirin Subjects with uncontrolled severe hypertension Subjects with high risk of hemorrhage like blood coagulation disorders :gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage Subjects with intractable arrhythmia, intracranial hemorrhage Subjects with Severe cardiomyopathy (New York Heart Association(NYHA) Class Ⅳ) Subjects with Severe hepatopathy(AST and ALT > 10 times the upper limit of normal) Subjects who are pregnant, breastfeeding and not using medically acceptable birth control Subjects considered as unsuitable based on medical judgement by investigators

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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: Closone<br>75mg/100mg per day, 4weeks, PO | Drug: Closone<br>* Closone 75mg/100mg, 4weeks, PO<br>|
| Active Comparator: Plavix with Astrix<br>Plavix 75mg with Astrix 100mg, 4weeks, PO | Drug: Plavix with Astrix<br>* Plavix 75mg with Astrix 100mg, 4weeks, PO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in P2Y12% inhibition at week 4 |  | Baseline, week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in VerifyNow P2Y12 reaction unit at week 4 | PRU : VerifyNow P2Y12 reaction unit | Baseline, week 4 | 
| Change from baseline in VerifyNow Aspirin Reaction Unit at week 4 | ARU : VerifyNow Aspirin Reaction Unit | Baseline, week 4 | 
| Change from baseline in maxymal platelet aggregation at week 4 | MPA : maxymal platelet aggregation | Baseline, week 4 |