Clinical trial NCT01147133: Comparison of Generic and Original Formulation of Clopidogrel
Official title: Comparison of the Generic and Original Formulation of Clopidogrel Regarding the Potency of Platelet Inhibition in Patients After PCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Heart Disease
Percutaneous Coronary Intervention
Keywords: Platelet aggregation
Generic
Clopidogrel
Comparison
VASP-PRI
Lead sponsor: University of Pecs
Sponsor class: OTHER
Collaborators: name: Hungarian Academy of Sciences
name: KRKA
First posted: 2010-06-22
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

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 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

Primary outcomes:
measure: ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point.
timeFrame: 14 days
Secondary outcomes:
measure: VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR)
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Pécs, HUNGARY
name: Daniel Aradi, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pécs, HUNGARY
name: András Komócsi, MD PhD
role: STUDY_DIRECTOR
References: