A pilot study investigating the antiplatelet effect of generic clopidogrel versus Plavix™ – is there any difference in platelet reactivity in healthy subjects? - The effect of Plavix versus generic clopidogrel on platelet reactivity

Conditions: The intended indication for the product is for use in all patients with acute coronary syndromes and following coronary artery stenting

Registration Number: EUCTR2010-022461-10-GB

Lead Sponsor: Southampton University Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 15

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>Platelet reactivity will be measured using Thromboelastography (TEG) Platelet Mapping.

Secondary Outcome Measures