RESPOND - antiplatelet effects of AZD6140 compared with clopidogrel
Research type
Research Study
Full title
A randomised, double-blind, outpatient, crossover study of the anti-platelet effects of AZD6140 compared with clopidogrel in patients with stable coronary artery disease previously identified as clopidogrel non-responders or responders (RESPOND).
IRAS ID
10264
Sponsor organisation
AstraZeneca
Eudract number
2008-005305-19
ISRCTN Number
N/a
Clinicaltrials.gov Identifier
Research summary
A leading cause of death and disability are disorders resulting from a blood clot in the vessels (arteries) supplying blood to the heart or brain and to the rest of the body. The importance of platelets (cells present in blood) in the development of blood clots that block arteries has been clearly shown. Anti-platelet drugs are currently available to reduce the occurrence of blood clots. However, they are slow to start working, their effects cannot be reversed and they are not completely effective. There is a medical need for better anti-platelet treatments. This study aims to find out how an anti-platelet experimental drug called AZD6140, affects platelets compared with clopidogrel, a currently used anti-platelet drug. Anti-platelet drugs block the formation of blood clots by preventing the clumping or sticking together of platelets. In some patients clopidogrel has very little effect on their platelets and these patients are called non-responders, whereas other patients seem to have a typical response to clopidogrel anti-platelet effects, and these patients are known as responders. This study is comparing the anti-platelet effects of AZD6140 with clopidogrel in patients with coronary artery disease identified as clopidogrel non-responders or responders. Also, the effects of switching directly from clopidogrel to AZD6140 and from AZD6140 to clopidogrel, in clopidogrel responsive patients, will be determined.Approximately eighty patients from North America and several European countries will take part; about ten to fifteen patients will be recruited from the UK. There are five study visits over a period of seven weeks. At the visits patients will be asked to give blood samples for specialised platelet assessments and for routine blood tests. Other assessments will include giving a urine sample, ECG, physical examination and measurement of height, weight, temperature, blood pressure, heart rate and respiratory rate (breaths taken per minute).
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
08/H1307/143
Date of REC Opinion
22 Jan 2009
REC opinion
Further Information Favourable Opinion