The intended indication for the product is for use in all patients with acute coronary syndromes and following coronary artery stenting
Conditions
Interventions
Trade Name: Plavix (Clopidogrel hydrogen sulphate)
Product Name: Plavix
Product Code: N/A
Pharmaceutical Form: Coated tablet
INN or Proposed INN: hydrogen sulphate
CAS Number: 135046-48-9
Current Spon
Sponsors
Southampton University Hospitals NHS Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Age > 18 years Male Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Age > 65 years Female Smoker Antiplatelet or non-steroidal anti-inflammatory medication administered within the previous 14 days Known clopidogrel intolerance Surgery planned within 4 weeks History of peptic ulceration or recent bleeding On regular prescribed medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is the antiplatelet effect (prevention of platelets from binding together and forming blood clots) of generic clopidogrel equivalent to Plavix and is it therefore potentially safe to use generic clopidogrel in routine clinical practice as an alternative to Plavix?;Secondary Objective: Not applicable;Primary end point(s): To assess whether there is any intra- and/or inter-individual variability in platelet reactivity in response to generic clopidogrel versus Plavix. Platelet reactivity will be measured using Thromboelastography (TEG) Platelet Mapping. | — |
Countries
United Kingdom
Outcome results
None listed