Comparison of Generic and Original Formulation of Clopidogrel

NCT01147133 | Completed Phase 4

• 1 other identifier: DOSER-GENERIC
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Heart Disease; Percutaneous Coronary Intervention

Keywords

Platelet aggregation; Generic; Clopidogrel; Comparison; VASP-PRI

Outcome Measures

Primary Outcomes (1)

• ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point.

  14 days

Secondary Outcomes (1)

• VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR)

  14 days

Study Arms (2)

Original

EXPERIMENTAL

Treatment phase with the original formulation of clopidogrel

Drug: Plavix

Generic

ACTIVE COMPARATOR

Treatment phase with the generic clopidogrel

Drug: Kardogrel

Interventions

Plavix DRUG

1x75 mg

Also known as: clopidogrel = PLAVIX

Original

Kardogrel DRUG

1x75 mg

Also known as: generic clopidogrel = Kardogrel

Generic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Oral anticoagulant therapy
• Contraindication for aspirin or clopidogrel
• Planned interruption of antiplatelet therapy in the next month

Sponsors & Collaborators

• University of Pecs: lead
• Hungarian Academy of Sciences: collaborator
• KRKA: collaborator

MeSH Terms

Conditions

Coronary Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Daniel Aradi, MD PhD

  University of Pécs, HUNGARY

  PRINCIPAL INVESTIGATOR

• András Komócsi, MD PhD

  University of Pécs, HUNGARY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 22, 2010
• Study Start: November 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 29, 2013

Record last verified: 2013-01