Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-26 @ 8:33 AM
Study NCT ID:
NCT01147133
Status:
COMPLETED
Last Update Posted:
2013-01-29
First Post:
2010-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Generic and Original Formulation of Clopidogrel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-28', 'studyFirstSubmitDate': '2010-06-16', 'studyFirstSubmitQcDate': '2010-06-17', 'lastUpdatePostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point.', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR)', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Platelet aggregation', 'Generic', 'Clopidogrel', 'Comparison', 'VASP-PRI'], 'conditions': ['Coronary Heart Disease', 'Percutaneous Coronary Intervention']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn a prospective, cross-over, open-label, unblinded study the investigators aim to compare platelet activation and aggregation between Plavix® and generic clopidogrel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in the maintenance phase of PCI receiving 1x75 mg clopidogrel and 1x100 mg aspirin\n* No planned interruption of the antiplatelet therapy in the next 1 month\n* Informed consent\n\nExclusion Criteria:\n\n* Oral anticoagulant therapy\n* Contraindication for aspirin or clopidogrel\n* Planned interruption of antiplatelet therapy in the next month'}, 'identificationModule': {'nctId': 'NCT01147133', 'acronym': 'DOSER-GENERIC', 'briefTitle': 'Comparison of Generic and Original Formulation of Clopidogrel', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'Comparison of the Generic and Original Formulation of Clopidogrel Regarding the Potency of Platelet Inhibition in Patients After PCI', 'orgStudyIdInfo': {'id': 'DOSER-GENERIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Original', 'description': 'Treatment phase with the original formulation of clopidogrel', 'interventionNames': ['Drug: Plavix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Generic', 'description': 'Treatment phase with the generic clopidogrel', 'interventionNames': ['Drug: Kardogrel']}], 'interventions': [{'name': 'Plavix', 'type': 'DRUG', 'otherNames': ['clopidogrel = PLAVIX'], 'description': '1x75 mg', 'armGroupLabels': ['Original']}, {'name': 'Kardogrel', 'type': 'DRUG', 'otherNames': ['generic clopidogrel = Kardogrel'], 'description': '1x75 mg', 'armGroupLabels': ['Generic']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Daniel Aradi, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pécs, HUNGARY'}, {'name': 'András Komócsi, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pécs, HUNGARY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hungarian Academy of Sciences', 'class': 'OTHER'}, {'name': 'KRKA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Professor', 'investigatorFullName': 'Daniel Aradi MD', 'investigatorAffiliation': 'University of Pecs'}}}}