Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®)

Study Overview
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Brief Summary
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This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.

Official Title
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Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®)

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: generic clopidogrel (Plavitor® )
* Drug: original clopidogrel (Plavix® )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unstable angina or non-ST elevation myocardial infarction Patients who are planned coronary angiography Age >18 years, <75 years Patients who agree to the study protocol Exclusion Criteria: Recent treatment with clopidogrel or pletaal or glycoprotein IIb/IIIa Rc antagonist Active bleeding (peptic ulcer, trauma or intra-cranial hemorrhage) Allergy to antiplatelet agent Bleeding diasthesis (blood coagulation disorders, uncontrolled severe hypertension, history of severe bleeding) History of drug abuse or alcohol abuse ST elevation myocardial infarction Pregnancy Low platelet count (< 100,000 /L) or abnormal results of PT or PTT Liver disease ( bilirubin > 2 mg/dL, AST or ALT > 100 IU) Renal failure ( Cr > 2.0 mg/dL) Malignancy Proton pump inhibitor, NSAIDs statin (except atorvastatin)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 74 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 |
| --- | --- |
| Active Comparator: original Clopidogrel Bisulfate (Plavix®)<br>original Clopidogrel Bisulfate (Plavix®) 600mg loading | Drug: original clopidogrel (Plavix® )<br> <br> |
| Experimental: generic Clopidogrel Bisulfate (Plavitor®)<br>generic Clopidogrel Bisulfate (Plavitor®) 600mg loading | Drug: generic clopidogrel (Plavitor® )<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRU level at 2 hours after clopidogrel loading |  | 2 hours after clopidogrel loading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading |  | 4 -, 8- and 24 hours after clopidogrel loading | 
| ARU level by VerifyNow before and 2 hours after loading |  | 2 hours after loading | 
| Composite of death, myocardial infarction, target vessel revascularization |  | at 30 days | 
| Stent thrombosis by Academic Research Consortium definition |  | at 30 days | 
| Incidence of TIMI major bleedings |  | at 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiplatelet; clopidogrel; acute coronary syndrome