CYP2C19 variants in predicting clopidogrel efficacy
Research type
Research Study
Full title
The role of CYP2C19 variants in predicting the efficacy of the anti-platelet drug clopidogrel.
IRAS ID
208260
Contact name
Gavin Galasko
Contact email
Sponsor organisation
Blackpool Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Title: The Role of Gene CYP2C19 Variants in Predicting the Efficacy of the Antiplatelet Drug Clopidogrel
Summary: Clopidogrel, an anti-platelet drug, is commonly prescribed in patients with heart disease as it makes platelets less sticky, reducing the risk of blood clots and further cardiac events. Clopidogrel, however, does not appear to work equally in everybody. In some people it does not appear to inhibit platelets. These patients might be at higher risk of future cardiac events.
The CYP2C19 gene appears to affect how well Clopidogrel works and different people have different versions of this gene. Detecting what type of CYP2C19 gene an individual has may tell how well they will respond to Clopidogrel.
This study would measure how well Clopidogrel is working in individuals by testing their platelet function using two validated blood tests. It would identify the type of CYP2C19 gene that individual has, using a new blood test, and thus determine whether this new genetic blood test predicts how well individuals respond to Clopidogrel.
We aim to recruit 150 participants who have been taking clopidogrel for at least 28 days, from our hospital’s pharmacy database. They will be invited to the Cardiology research department to have blood tests to measure their platelet function and their CYP2C19 gene subtype. With individual consent, the genetic material extracted for CYP2C19 analysis (DNA samples) will be stored for future analyses. Basic demographic data would also be collected. Data collected will be stored securely and anonymised.
The observational study is not aimed at changing the participants’ medications. However, if participants are found to be a poor responder to Clopidogrel, their GP and responsible physician will be notified accordingly and alternative therapy may be advised. Participation in the study is completely optional and participants may withdraw at any time.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
16/YH/0482
Date of REC Opinion
15 Nov 2016
REC opinion
Favourable Opinion