Bleeding in patients on antithrombotic therapy
Research type
Research Study
Full title
CardiovASCulAr and bleeDing outcomEs associated with antithrombotic therapy (CASCADE) study
IRAS ID
238646
Contact name
Mark Thomas
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Harmful blood clotting (thrombosis) plays a major role in many different cardiovascular diseases including heart attacks, deep vein thrombosis and stroke. It is well-established that anti-blood clotting medications are an effective treatment in a variety of clinical settings. However, these medications can cause spontaneous bleeding, which may be severe. It is now recognised that severe bleeding is actually as harmful as a recurrent thrombotic event. Therefore, new cardiovascular treatment strategies have been able to reduce the risk of death in patients by reducing the risk of severe bleeding whilst maintaining the same cardiovascular benefit as existing treatment strategies.
The aim of this study is to identify risk factors for bleeding and recurrent thrombosis in patients that are treated with anti-blood clotting medications. The study will identify which molecular and cellular mechanisms related to blood clotting are the most important in determining whether or not a patient will suffer a spontaneous bleed. It will also determine whether markers of function of the clotting system can be combined with other important parameters (such as clinical details, past medical history, concurrent medications) to predict subsequent spontaneous bleeding. In combination, these findings have the potential to drive the development of new anti-blood clotting treatment strategies that minimise the risk of bleeding. This has the potential to improve patient mortality and reduce the unwanted side effects of these treatments.
This will be an observational, longitudinal study of 1,184 patients treated with antithrombotic therapy and 44 age- and sex-matched controls that are not treated with antithrombotic therapy. We will record clinical details and we will perform a heart tracing and take samples of blood and urine for analysis. Patients will return after 2 years (and 1 month in some patients) so that we can assess whether they have suffered from bleeding or recurrent thrombotic events.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
18/WM/0386
Date of REC Opinion
5 Mar 2019
REC opinion
Further Information Favourable Opinion