Background;
Stroke is the second leading cause of global death, leading cause of acquired disability, and a major contributor to dementia and healthcare costs. The WHO predict that the societal burden of stroke will substantially increase, due to ageing populations and increased risk factors in low- and middle-income countries. In recent years, Stroke Research Networks have been established in the UK, USA, Canada, and Australia, leading to improvements in stroke therapies.
Aim:
We aim to establish a sustainable Stroke Clinical Trials Network of 8 Irish hospitals affiliated with all 6 leading Irish universities, Hospital Groups, and Clinical Research Centres. We aim to establish governance, management, training, communications, and fundraising capacity which will 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.
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. 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.
Existing stroke clinical trials will be partnered with the Network. We will lead one major international Definitive Intervention trial, to investigate the benefit and safety of high-dose immediate statin therapy (atorvastatin 80mg) versus placebo/usual care to prevent early recurrent stroke and myocardial infarction in high-risk patients with non-cardioembolic minor ischaemic stroke and transient ischaemic attack. We will develop a portfolio of additional acute, prevention, and recovery trials along a pathway of pilot/feasibility studies, application for new funding, and definitive intervention.
