Trial to Assess the Efficacy of Combination Formula of Aspirin Plus Clopidogrel in Patients With Coronary Stent

Study Overview
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Brief Summary
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The purpose of this study in to evaluate efficacy and tolerability of Clopirin and clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery intervention.

Official Title
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Multicenter, Randomized, Open Study, Investigator-initiated Trial for Comparison of Eight Weeks Efficacy and Tolerability of Clopirin and Clopidogrel With Aspirin in Korean Patients With Post-Percutaneous Coronary Artery Intervention

Conditions
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ANEURYSM CORONARY ARTERY

Intervention / Treatment
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* Drug: Clopirin 1
* Drug: Clopidogrel-Aspirin(co-administration) 1
* Drug: Clopirin 2
* Drug: Clopidogrel-Aspirin(co-administration) 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 3 months, the patient who were the administration of aspirin or the co-administration of clopidogrel-aspirin coronary artery patients after treated with Percutaneous Coronary Intervention(PCI) that have safety progress. Korean men and women between the age of 20 and 85 Patients who understand the study requirements, are willing to comply with all study procedures and have provided written informed consent. Exclusion Criteria: Patients who were not treated with PCI or intended to treat with PCI but failed. Patients who were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days. Patients who had a history of alcohol abuse or intoxication. Patients who had hypersensitivity to clopidogrel or aspirin. Patients who had severe hepatic dysfunction aspartate aminotransferase(AST) or alanine aminotransferase(ALT) > 3 times upper normal reference values. Patients who had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding - surgery within 48hr, platelet counts below 50,000/mm3 in laboratory tests. Patients who were pregnant, breastfeeding. Patients who were not using effective methods of contraception. (proper contraception : hormonal contraception, condom, intrauterine device, spermicide) Patients who medically, psychologically had investigational product administration's prohibition. Patients who were not participated in this clinical trial decided by other 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: Clopirin 1<br>Clopirin single-administration. Before this clinical trial Clopidogrel/Aspirin co-administration. | Drug: Clopirin 1<br> <br> |
| Active Comparator: Clopidogrel/Aspirin co-administration 1<br>Clopidogrel-aspirin co-administration. Before this clinical trialClopidogrel/Aspirin co-administration. | Drug: Clopidogrel-Aspirin(co-administration) 1<br> <br> |
| Experimental: Clopirin 2<br>Clopirin single-administration. Before this clinical trial Aspirin single-administration. | Drug: Clopirin 2<br> <br> |
| Active Comparator: Clopidogrel/Aspirin co-administration 2<br>Clopidogrel-aspirin-co-administration. Before this clinical trial Aspirin single-administration. | Drug: Clopidogrel-Aspirin(co-administration) 2<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| △ PRU = Post treatment PRU - Pre treatment PRU |  | 8 weeks | 
| △ ARU = Post treatment Aspirin resistance unit(ARU) - Pre treatment ARU |  | 8 weeks |