Comparison of Effect & Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients

Study Overview
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Brief Summary
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The aim of this study is to demonstrate that the combination therapy of aspirin and clopidogrel napadisilate is not inferior to that of aspirin and clopidogrel bisulfate with respect to its effectiveness in inhibiting platelet aggregation, if it is given for four weeks to Coronary Artery Disease (CAD) patients who had been treated with a drug-eluting stent before > 12 months and had remained in a stable condition with a single antiplatelet agent, aspirin.

Official Title
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Comparison of Antiplatelet Effect and Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients: Multi-center, Randomized, Double-blind, Phase IV Clinical Trial

Conditions
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Coronary Artery Disease (CAD)

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: aspirin 100mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 20 to 80 years men and women with coronary artery disease who had been treated with drug-eluting stent placement before > 12 months patients who had remained in a stable condition with a single antiplatelet agent, aspirin patients who did not show any sign or symptom of the worsening of their angina within the last six months that required a coronary artery intervention, a coronary artery bypass, or coronary angiography Exclusion Criteria: Patients who were taking another antiplatelet or anticoagulant drug such as clopidogrel, warfarin, or cilostazol in addition to aspirin, unless they could withdraw from such other drug/s, in which case they could be enrolled in the study after a two-week wash-out period Patients who were suffering from drug abuse or alcohol addiction hypersensitivity to clopidogrel or aspirin severe liver disease (ALT or AST ≥ 10 times the upper normal limit) active hemorrhage such as gastro-intestinal ulcer or intracranial hemorrhage a high risk of bleeding (blood coagulation disorder, uncontrolled severe hypertension, active bleeding, or history of severe bleeding) pregnant or lactating women women with childbearing potential who were not using an appropriate contraception method had medical or mental contra-indications to the study treatment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clopidogrel napadisilate<br>aspirin 100mg | Drug: Clopidogrel<br> <br> * Other names: Plavix®;Drug: aspirin 100mg<br> <br> |
| Active Comparator: clopidogrel bisulfate<br>aspirin 100mg | Drug: Clopidogrel<br> <br> * Other names: Plavix®;Drug: aspirin 100mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percent inhibition of the platelet aggregation change |  | baseline and 4weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of P2Y12 reaction unit (PRU) |  | baseline and 4weeks |