Comparison of Generic and Original Formulation of Clopidogrel

Phase 4

Completed

• Conditions: Coronary Heart Disease; Percutaneous Coronary Intervention
• Interventions: Drug: Plavix; Drug: Kardogrel

• Registration Number: NCT01147133
• Lead Sponsor: University of Pecs

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.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Original	Plavix	Treatment phase with the original formulation of clopidogrel
Generic	Kardogrel	Treatment phase with the generic clopidogrel

Primary Outcome Measures

Name	Time	Method
ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point.	14 days

Secondary Outcome Measures

Name	Time	Method
VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR)	14 days