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

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ClinicalTrials.gov Identifier: NCT01147133
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : January 29, 2013
Sponsor:
Collaborators:
Hungarian Academy of Sciences
KRKA
Information provided by (Responsible Party):
Daniel Aradi MD, University of Pecs

Tracking Information
First Submitted Date  ICMJE June 16, 2010
First Posted Date  ICMJE June 22, 2010
Last Update Posted Date January 29, 2013
Study Start Date  ICMJE November 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2010)
ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point. [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2010)
VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR) [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Generic and Original Formulation of Clopidogrel
Official Title  ICMJE Comparison of the Generic and Original Formulation of Clopidogrel Regarding the Potency of Platelet Inhibition in Patients After PCI
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Coronary Heart Disease
  • Percutaneous Coronary Intervention
Intervention  ICMJE
  • Drug: Plavix
    1x75 mg
    Other Name: clopidogrel = PLAVIX
  • Drug: Kardogrel
    1x75 mg
    Other Name: generic clopidogrel = Kardogrel
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2010)
75
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01147133
Other Study ID Numbers  ICMJE DOSER-GENERIC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Aradi MD, University of Pecs
Study Sponsor  ICMJE University of Pecs
Collaborators  ICMJE
  • Hungarian Academy of Sciences
  • KRKA
Investigators  ICMJE
Principal Investigator: Daniel Aradi, MD PhD University of Pécs, HUNGARY
Study Director: András Komócsi, MD PhD University of Pécs, HUNGARY
PRS Account University of Pecs
Verification Date January 2013

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