Trial | NCT01147133  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    clopidogrel ...

  • Study Participants

    75
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.
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.
Study Started
Nov 30
2009
Primary Completion
Apr 30
2010
Study Completion
May 31
2010
Last Update
Jan 29
2013
Estimate

Drug Plavix

1x75 mg

  • Other names: clopidogrel = PLAVIX

Drug Kardogrel

1x75 mg

  • Other names: generic clopidogrel = Kardogrel

Original Experimental

Treatment phase with the original formulation of clopidogrel

Generic Active Comparator

Treatment phase with the generic clopidogrel

Criteria 

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
No Results Posted