The effect of Plavix versus generic clopidogrel on platelet reactivity

• Research type

  Research Study

• Full title

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

• IRAS ID

  59719

• Contact name

  Nicholas Curzen

• Sponsor organisation

  Southampton University Hospitals NHS Trust

• Eudract number

  2010-022461-10

• ISRCTN Number

  Not available

• Research summary

  Clopidogrel is an essential antiplatelet agent (drug used to prevent platelets from binding together and forming blood clots) that is widely used in the treatment of cardiovascular disease as well as in all patients undergoing coronary stent implantation to reduce the risk of adverse events including potentially fatal stent thrombosis (blood clots forming within stents). Clopidogrel exists in various different salt formulations (the specific salt formulation of a drug determines its clinical effectiveness and the extent to which it is absorbed and distributed within the body). All previous clinical studies that have demonstrated the beneficial effects of clopidogrel are based entirely on the hydrogen sulphate salt which is contained in the branded product Plavix. A number of inexpensive generic versions of clopidogrel have recently been introduced to the UK pharmaceutical market. There is very limited data supporting the use of these alternative salts and there is insufficient evidence to show that their biological effect is equivalent to Plavix. Despite this, there is mounting pressure, mainly for financial reasons, to adopt the use of these agents in routine clinical practice including in patients undergoing coronary stenting potentially exposing them to an increased risk of adverse events. Our study will determine whether there is any difference between the antiplatelet effect of generic clopidogrel versus Plavix. - 15 healthy volunteers will be recruited from SUHT- They will receive a 300mg loading dose of Plavix followed by a 75mg daily dose for 7 days- After a washout period of 2 weeks they will receive the same dosage regime of generic clopidogrel Blood tests to determine platelet reactivity will be undertaken:(i) immediately prior to, 1, 2 and 6 hours after administration of the 300mg loading dose(ii)7 days after taking the 75mg daily dose Participation in the study will end after approximately 4 weeks.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  10/H0504/92

• Date of REC Opinion

  8 Feb 2011

• REC opinion

  Further Information Favourable Opinion