Antiplatelet Secondary Prevention International Randomised trial after INtracerebral haemorrhaGe (ASPIRING): a pragmatic, randomised, parallel group, open, superiority, phase 3 GCRFF multinational clinical trial. Application for international coordination and UK national contributions.

Stroke due to non-traumatic intracerebral haemorrhage (ICH) accounts for 54% of years of life lost due to stroke worldwide and survivors are at 7-19% annual risk of further major adverse cardiovascular events (MACE). In the Primary Applicant's recent BHF-funded REstart or STop Antithrombotics Randomised Trial (RESTART) for people with symptomatic occlusive vascular disease who survived ICH in the UK, starting antiplatelet therapy appeared safe and may have reduced the risk of MACE. Now, we seek to determine these effects in all ICH survivors and investigate their generalisability worldwide in the Antiplatelet Secondary Prevention International Randomised trial after INtracerebral haemorrhaGe (ASPIRING). ASPIRING will recruit ≥4,148 participants aged ≥18 years who survive ≥24 hours after symptomatic ICH and have not started antiplatelet or anticoagulant drug therapy after ICH at 178 hospitals worldwide. Central computerised randomisation will allocate participants (1:1) to start or to avoid antiplatelet monotherapy. All randomised participants will be followed for the primary composite outcome of all ischaemic and haemorrhagic MACE (non-fatal stroke, non-fatal myocardial infarction, or vascular death). ASPIRING will provide definitive evidence about the effects of antiplatelet monotherapy on MACE in all ICH survivors, explore generalisability and estimate effects in important sub-groups. ASPIRING will influence clinical guidelines worldwide.