Thrombotic status in patients with coronary disease
Research type
Research Study
Full title
Assessment of thrombotic status in patients with coronary disease
IRAS ID
153405
Contact name
Diana Gorog
Contact email
Sponsor organisation
East & North Hertfordshire NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Patients presenting with acute coronary syndrome (ACS) are at increased risk of future cardiovascular events, despite optimal medical treatment and coronary intervention. Such events are usually caused by increased stickiness of the blood causing a blood clot (thrombus) to block arterial blood vessels in the heart. Much of the medication to prevent recurrent thrombotic events increases the risk of bleeding complications. We will assess the stickiness of the blood (i.e. thrombotic status) in patients who are admitted to hospital with ACS; at baseline, at discharge from hospital and at 30 days post hospitalisation, to see how disease status and clinical treatments affect the stickiness of the blood. Patients will be followed up by members of the research team in person or via telephonic consultation at 30 days, 6 months, 1 year and 2 years after the index event for the occurrence of the co-primary endpoints of major adverse cardiovascular events (myocardial infarction, stroke or death), and major bleeding. The secondary endpoint of repeat revascularisation will also be assessed. Blood stickiness will be tested using a number of tests of thrombotic status including thrombin generation assays, Thromboelastography (TEG) and the near-patient, point-of-care Global Thrombosis Test (GTT). The results will be evaluated to assess the effect of disease process and clinical state on blood stickiness to gain further understanding of this condition. The aim of this study is to validate whether thrombotic status (thrombin generation and global thrombotic tests) can predict adverse cardiovascular events and bleeding in this cohort of patients.
REC name
London - Fulham Research Ethics Committee
REC reference
15/LO/0042
Date of REC Opinion
28 Jan 2015
REC opinion
Further Information Favourable Opinion