A Phase 4 interventional study of Plavix and Kardogrel in Coronary Heart Disease and Percutaneous Coronary Intervention, sponsored by University of Pecs. Completed. Per ClinicalTrials.gov, last updated 2013-01-29.
Sponsored by University of Pecs · Phase 4, Interventional, and Diagnostic
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.
2,867 studies on the registry are indexed under Coronary Disease; 309 are open to participants now.
This study's enrollment of 75 is below the median of 124 across 1,601 interventional studies indexed under Coronary Disease.
Browse Coronary Disease studies →University of Pecs is the lead sponsor of 105 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Treatment phase with the original formulation of clopidogrel
Drug: Plavix
Treatment phase with the generic clopidogrel
Drug: Kardogrel
1x75 mg
Also known as: clopidogrel = PLAVIX
1x75 mg
Also known as: generic clopidogrel = Kardogrel
ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point.
Time frame: 14 days
VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR)
Time frame: 14 days
No study locations are listed for this record.
The record gives a start of Nov 2009, a primary completion of Apr 2010 and a completion of May 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clopidogrel