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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01147133
First Posted: June 22, 2010
Last Update Posted: January 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hungarian Academy of Sciences
KRKA
Information provided by (Responsible Party):
Daniel Aradi MD, University of Pecs
  Purpose
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.

Condition Intervention Phase
Coronary Heart Disease Percutaneous Coronary Intervention Drug: Plavix Drug: Kardogrel Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of the Generic and Original Formulation of Clopidogrel Regarding the Potency of Platelet Inhibition in Patients After PCI

Resource links provided by NLM:


Further study details as provided by Daniel Aradi MD, University of Pecs:

Primary Outcome Measures:
  • ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point. [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR) [ Time Frame: 14 days ]

Enrollment: 75
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Original
Treatment phase with the original formulation of clopidogrel
Drug: Plavix
1x75 mg
Other Name: clopidogrel = PLAVIX
Active Comparator: Generic
Treatment phase with the generic clopidogrel
Drug: Kardogrel
1x75 mg
Other Name: generic clopidogrel = Kardogrel

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.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147133


Sponsors and Collaborators
University of Pecs
Hungarian Academy of Sciences
KRKA
Investigators
Principal Investigator: Daniel Aradi, MD PhD University of Pécs, HUNGARY
Study Director: András Komócsi, MD PhD University of Pécs, HUNGARY
  More Information

Responsible Party: Daniel Aradi MD, Assisstant Professor, University of Pecs
ClinicalTrials.gov Identifier: NCT01147133     History of Changes
Other Study ID Numbers: DOSER-GENERIC
First Submitted: June 16, 2010
First Posted: June 22, 2010
Last Update Posted: January 29, 2013
Last Verified: January 2013

Keywords provided by Daniel Aradi MD, University of Pecs:
Platelet aggregation
Generic
Clopidogrel
Comparison
VASP-PRI

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors