Comparison of bleeding after ACS between ticagrelor and clopidogrel
Research type
Research Study
Full title
The risk of major bleeding with novel anti-platelets: A comparison of ticagrelor with clopidogrel in a real world population of patients treated for acute coronary syndrome
IRAS ID
147388
Contact name
Aleem Khand
Contact email
Sponsor organisation
University Hospital Aintree
Duration of Study in the UK
1 years, 1 months, 23 days
Research summary
Following the recent PLATO trial, ticagrelor has been recommended in ESC and NICE guidelines for the treatment of acute coronary syndromes. The ACS guidelines at Aintree University Hospital and within Mersey Network were recently altered; with Ticagrelor replacing the previously recommended clopidogrel in 2012/13. There have been concerns raised of potential increased bleeding risk with ticagrelor in a “real world” population given its more potent anti-platelet effect. The PLATO trial did not show any statistically significant difference in overall bleeding between clopidogrel and ticagrelor. There was however an increase incidence of non-CABG related major bleeding and the average age of subjects within the study was 10 years younger than the mean age of ACS patients in the UK. Also there were a higher proportion of men compared to women than would be seen in UK demographic data. One may therefore postulate that the incidence of bleeding with ticagrelor in a “real world” population, including more high risk patients, may be higher. We intend to compare the incidence of bleeding with ticagrelor and clopidogrel used for treatment of ACS amongst patients at five hospitals within the Mersey network; Aintree University Hospital, Royal Liverpool University Hospital, Warrington, Whiston and Chester Hospitals. Data will be collected retrospectively. We aim to collect data on the last 2500 patients receiving clopidogrel for ACS as a new prescription prior to the change in guidelines. We will then collect data on a similar number of patients given ticagrelor after the change in guidelines for the same indication. We intend to collect data using patient's paper and electronic case notes. We will also intend to access mortality data from a national registry. We will not be contacting patients directly or influencing management in any way. In this regard it is an observational study.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
14/NW/1326
Date of REC Opinion
9 Oct 2014
REC opinion
Favourable Opinion