Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and Closone

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

Official Title
-----------------
Multi-center, Randomized, Open Study for Comparison of Efficacy and Safety of Plavix With Astrix and Closone in Patients With Post-Percutaneous Coronary Artery Intervention

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects under a stable condition after Post-Percutaneous Coronary Artery Intervention over three months 20 86 years old Willing to adhere to protocol requirements and sign a informed consent form Exclusion Criteria: Subject who did not undergo or failed Drug-Stent Implantation Subjects who took an anti-coagulant, anti-thrombotic regularlly( ≥ 2weeks in a month) before the study, or plan to have continuous treatment during the study(Except Aspirin alone or combination of Aspirin and Clopidogrel) Subjects with a history of substance or alchol abuse Subjects with a history of hypersensitivity to Clopidogrel, Aspirin or other NSAIDS Subjects having Aspirin or other NSAIDs-induced Asthma or history Subjects with Severe hepatopathy(AST and ALT > 5 times the upper limit of normal) Subjects with Severe nephropathy(Cr > 3 times the upper limit of normal) Subjects with hemorrhage like gastric ulcer, intracranial hemorrhage etc. Subjects with high risk of hemorrhage like blood coagulation disorders, uncontrolled severe hypertension, active bleeding, history of severe bleeding subjects who are pregnant, breastfeeding Subjects not using medically acceptable birth control Subjects who are unsuitable to take the Investigational product due to a medical/mental condition Subjects inherently having Galactose malobsorption, Lactase deficiency or Glucose-Galactose malobsorption

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Closone<br>75mg/100mg per day, 8weeks, PO | Drug: Closone<br>* 75mg/100mg, 8weeks, PO<br>|
| Active Comparator: Plavix with Astrix<br>75mg per day, 8weeks, PO 100mg per day, 8weeks, PO | Drug: Plavix with Astrix<br>* 75mg, 100mg a day, 8weeks, PO<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baselinine in P2Y12% inhibition at week 8 |  | Baseline, week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PRU, ARU at week 8 |  | Baseline, week 8 |