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
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