Comparison of Generic and Original Formulation of Clopidogrel

Study Overview
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Brief Summary
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Clopidogrel is essential for the prevention of vascular events in patients after percutaneous coronary interventions (PCI). Most of our current knowledge with clopidogrel originates from the clinical investigations that had used Plavix®/Iscover® from Sanofi-Aventis as the original formulation of clopidogrel-bisulphate. However, as the patency of Plavix® has expired in November 2009 in Hungary, several generic clopidogrel have been introduced to the market. Some of the generics are using the original bisulphate formulation, while others are with besylate salt of clopidogrel. Despite the differences in the clopidogrel-salts, the different carriers might also modulate the pharmacokinetic/pharmacodynamic profile of each drug. As the consequences of the impaired antiplatelet potency might be devastating, including stent thrombosis, the investigators sought to compare generic clopidogrel to the original blister by different assays of platelet aggregation.

Detailed Description
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Clopidogrel is essential for the prevention of vascular events in patients after percutaneous coronary interventions (PCI). Most of our current knowledge with clopidogrel originates from the clinical investigations that had used Plavix®/Iscover® from Sanofi-Aventis as the original formulation of clopidogrel-bisulphate. However, as the patency of Plavix® has expired in November 2009 in Hungary, several generic clopidogrel have been introduced to the market. Some of the generics are using the original bisulphate formulation, while others are with besylate salt of clopidogrel. Despite the differences in the clopidogrel-salts, the different carriers might also modulate the pharmacokinetic/pharmacodynamic profile of each drug. As the consequences of the impaired antiplatelet potency might be devastating, including stent thrombosis, the investigators sought to compare generic clopidogrel to the original blister by different assays of platelet aggregation. In a prospective, cross-over, open-label, unblinded study the investigators aim to compare platelet activation and aggregation between Plavix® and generic clopidogrel.

Official Title
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Comparison of the Generic and Original Formulation of Clopidogrel Regarding the Potency of Platelet Inhibition in Patients After PCI

Conditions
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Coronary Heart Disease, Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Plavix
* Drug: Kardogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in the maintenance phase of PCI receiving 1x75 mg clopidogrel and 1x100 mg aspirin No planned interruption of the antiplatelet therapy in the next 1 month Informed consent Exclusion Criteria: Oral anticoagulant therapy Contraindication for aspirin or clopidogrel Planned interruption of antiplatelet therapy in the next month
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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Original<br>Treatment phase with the original formulation of clopidogrel | Drug: Plavix<br>* 1x75 mg<br>* Other names: clopidogrel = PLAVIX;|
| Active Comparator: Generic<br>Treatment phase with the generic clopidogrel | Drug: Kardogrel<br>* 1x75 mg<br>* Other names: generic clopidogrel = Kardogrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point. |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR) |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet aggregation, Generic, Clopidogrel, Comparison, VASP-PRI