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

This study has been completed.
Sponsor:
Collaborators:
Hungarian Academy of Sciences
KRKA
Information provided by (Responsible Party):
Daniel Aradi MD, University of Pecs
ClinicalTrials.gov Identifier:
NCT01147133
First received: June 16, 2010
Last updated: January 28, 2013
Last verified: January 2013

June 16, 2010
January 28, 2013
November 2009
April 2010   (final data collection date for primary outcome measure)
ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01147133 on ClinicalTrials.gov Archive Site
VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Generic and Original Formulation of Clopidogrel
Comparison of the Generic and Original Formulation of Clopidogrel Regarding the Potency of Platelet Inhibition in Patients After PCI

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Coronary Heart Disease
  • Percutaneous Coronary Intervention
  • Drug: Plavix
    1x75 mg
    Other Name: clopidogrel = PLAVIX
  • Drug: Kardogrel
    1x75 mg
    Other Name: generic clopidogrel = Kardogrel
  • Experimental: Original
    Treatment phase with the original formulation of clopidogrel
    Intervention: Drug: Plavix
  • Active Comparator: Generic
    Treatment phase with the generic clopidogrel
    Intervention: Drug: Kardogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
May 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01147133
DOSER-GENERIC
No
Daniel Aradi MD, University of Pecs
University of Pecs
  • Hungarian Academy of Sciences
  • KRKA
Principal Investigator: Daniel Aradi, MD PhD University of Pécs, HUNGARY
Study Director: András Komócsi, MD PhD University of Pécs, HUNGARY
University of Pecs
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP