Comparison of Generic and Original Formulation of Clopidogrel

Coronary Heart Disease Clinical Trial

— DOSER-GENERIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147133
• Other study ID #: DOSER-GENERIC
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2010
• Last updated: January 28, 2013
• Start date: November 2009
• Est. completion date: May 2010

Study information

• Verified date: January 2013
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Institutional Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Drug:
• Plavix
1x75 mg
• Kardogrel
1x75 mg

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Pecs	Hungarian Academy of Sciences, KRKA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point.		14 days	No
Secondary	VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR)		14 days	No