Plavix and Prasugrel

• Research type

  Research Study

• Full title

  Assessing Platelet Inhibitory Response to Clopidogrel – Feasibility, Safety and Cost Analysis of a Tailored Platelet Inhibition Strategy for Elective PCI Patients

• IRAS ID

  36124

• Contact name

  Peter Schofield

• Sponsor organisation

  Papworth Hospital NHS Foundation Trust

• Eudract number

  2010-018435-18

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  For patients undergoing implantation of coronary stents, current national guidelines recommend antiplatelet therapy with aspirin 75mg and clopidogrel 75mg for 12 months following any procedure requiring a drug eluting stent (DES), whereas those receiving bare metal stents (BMS) receive 1 month. Despite compliance with these recommendations a significant proportion of patients (5-45%) are poor responders to clopidogrel, placing them at an increased risk of further coronary clot formation. A number of platelet function tests are available to measure the degree of platelet inhibition but numerous studies have failed to determine which of these is best in terms of predictive value. Recent data have shown that clopidogrel non-response can be improved by increasing the dose of clopidogrel. A new platelet inhibitor Prasugrel (Efient©) has also been shown to effect greater platelet inhibition than clopidogrel and in the Triton-TIMI 38 trial has demonstrated superiority to clopidogrel in preventing clot and heart attacks, with a modest increased bleeding risk in those <60kg, >75 years old and in patients with previous stroke and TIA. We aim to investigate the feasibility, safety and cost of using the bedside platelet assay VerifyNow-P2Y12 to guide optimal platelet inhibition in patients undergoing elective coronary stent implantation, compared with standard treatment, at a UK tertiary referral cardiology centre.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  10/H0305/15

• Date of REC Opinion

  31 Mar 2010

• REC opinion

  Further Information Favourable Opinion