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Comparison of Generic and Original Formulation of Clopidogrel

Information source: University of Pecs
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Heart Disease; Percutaneous Coronary Intervention

Intervention: Plavix (Drug); Kardogrel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Pecs

Official(s) and/or principal investigator(s):
Daniel Aradi, MD PhD, Principal Investigator, Affiliation: University of Pécs, HUNGARY
András Komócsi, MD PhD, Study Director, Affiliation: University of Pécs, HUNGARY

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point.

Secondary outcome: VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR)

Detailed description: 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: November 2009
Last updated: January 28, 2013

Page last updated: August 23, 2015

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