Comparison of Generic and Original Formulation of Clopidogrel (DOSER-GENERIC)

University of Pecs

Status and phase: Completed; Phase 4

Conditions: Percutaneous Coronary Intervention; Coronary Heart Disease

Treatments: Drug: Plavix; Drug: Kardogrel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01147133

DOSER-GENERIC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Original

Experimental group

Description:

Treatment phase with the original formulation of clopidogrel

Treatment:

Drug: Plavix

Generic

Active Comparator group

Description:

Treatment phase with the generic clopidogrel

Treatment:

Drug: Kardogrel