Comparison of Generic and Original Formulation of Clopidogrel (DOSER-GENERIC)
Primary Purpose
Coronary Heart Disease, Percutaneous Coronary Intervention
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Plavix
Kardogrel
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Heart Disease focused on measuring Platelet aggregation, Generic, Clopidogrel, Comparison, VASP-PRI
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Original
Generic
Arm Description
Treatment phase with the original formulation of clopidogrel
Treatment phase with the generic clopidogrel
Outcomes
Primary Outcome Measures
ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point.
Secondary Outcome Measures
VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR)
Full Information
NCT ID
NCT01147133
First Posted
June 16, 2010
Last Updated
January 28, 2013
Sponsor
University of Pecs
Collaborators
Hungarian Academy of Sciences, KRKA
1. Study Identification
Unique Protocol Identification Number
NCT01147133
Brief Title
Comparison of Generic and Original Formulation of Clopidogrel
Acronym
DOSER-GENERIC
Official Title
Comparison of the Generic and Original Formulation of Clopidogrel Regarding the Potency of Platelet Inhibition in Patients After PCI
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pecs
Collaborators
Hungarian Academy of Sciences, KRKA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Percutaneous Coronary Intervention
Keywords
Platelet aggregation, Generic, Clopidogrel, Comparison, VASP-PRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Original
Arm Type
Experimental
Arm Description
Treatment phase with the original formulation of clopidogrel
Arm Title
Generic
Arm Type
Active Comparator
Arm Description
Treatment phase with the generic clopidogrel
Intervention Type
Drug
Intervention Name(s)
Plavix
Other Intervention Name(s)
clopidogrel = PLAVIX
Intervention Description
1x75 mg
Intervention Type
Drug
Intervention Name(s)
Kardogrel
Other Intervention Name(s)
generic clopidogrel = Kardogrel
Intervention Description
1x75 mg
Primary Outcome Measure Information:
Title
ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR)
Time Frame
14 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Aradi, MD PhD
Organizational Affiliation
University of Pécs, HUNGARY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
András Komócsi, MD PhD
Organizational Affiliation
University of Pécs, HUNGARY
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Comparison of Generic and Original Formulation of Clopidogrel
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