The WHO estimates that stroke is the second leading cause of global death, leading cause of acquired disability, and a major contributor to dementia and healthcare costs. In recent years, Stroke Research Networks have been established in the UK, North America, and Australia, leading to improvements in stroke therapies.
Aim:
We aim to establish a sustainable Stroke Clinical Trials Network of 8 ‘core’ Irish hospitals affiliated with all 6 Irish universities, Hospital Groups, and Clinical Research Centres (CRCs). We aim to establish governance, management, training, communications, and fundraising capacity to improve the efficiency of conducting high-quality clinical trials of stroke prevention, acute treatment, and recovery, thus increasing access of Irish patients to new treatments. We will initiate and conduct one international randomised trial.
Methods:
Executive Management Committee, International Advisory Group, Coordinating Centre Operations Team, and Site Operations Teams will be established, in partnership with CRCs and international (UK/Scotland, US) Stroke Networks. Partnerships will be established with other HRB-funded core infrastructure including the Irish Trials Research Methodology Network, Data Management Unit at the Galway CRC, and Centre for Advanced Medical Imaging at the Welcome Trust-HRB CRC at St James’ Hospital Dublin. Strategic plans will be developed for Research, Sustainability, and Communications. Linkages will be developed with key stakeholders including patient groups, policy-makers, the Health Service Executive Clinical Care Programmes (including Stroke Programme), funding bodies, industry and health professionals. A fundraising programme will be implemented, targeting industry, Irish funders, and international funders, particularly EU Horizon 2020 programme.
Ongoing stroke trials will be partnered with the Network. We will lead one international Definitive Intervention trial, to investigate low-dose colchicine versus placebo plus usual care to prevent recurrent vascular events after minor noncardioembolic ischaemic stroke. We will develop a portfolio of additional trials along pilot/feasibility, application for new funding, and definitive intervention phases.