One of the most devastating complications of clot-busting treatment is bleeding into the brain, occurring in approximately 5% of treated patients. This research will examine ways of reducing this complication, by considering three important aspects of treatment within a large international clinical trial, ENCHANTED, which is funded in the UK by the Stroke Association until March 2016, with over 600 patients already recruited in the UK, the second highest recruiting country worldwide.
Firstly, two doses of a clot-busting drug are being assessed: the current licensed dose, and a lower dose already used in some parts of the world (e.g. Japan). This part of the trial finished ahead of schedule in late 2015, and could inform guidelines and patient treatment.
Secondly, does intensive blood pressure-lowering improve outcome compared to current guideline treatment, in particular; reduce the risk of bleeding into the brain as a complication of clot-busting treatment? So far, half of the required 2,400 patients have been recruited, and STAY ENCHANTED will fund UK centres to continue to recruit patients to blood pressure-lowering until late 2017.
Finally, all patients with suspected stroke have a brain scan, and it is possible that some features on the initial brain scan may help predict bleeding complications or other poor outcomes during clot-busting treatment. This is very important to confirm so that patients and their relatives can be given more reliable information about the potential risks and benefits of clot-busting treatment.
The STAY ENCHANTED funding will support the UK’s leadership of pooling brain imaging data from many clot-busting and BP-lowering trials, including ENCHANTED, to help answer this question and better inform patients and their relatives.