Comparison of Generic and Original Formulation of Clopidogrel
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
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.