Antiplatelet Secondary Prevention International Randomised trial after INtracerebral haemorrhaGe (ASPIRING): a pragmatic, randomised, parallel group, open, phase 3, international superiority trial

ASPIRING aims to improve the care of patients who survive stroke due to bleeding in the brain, known as "hemorrhagic stroke". Hemorrhagic strokes happen when weakened blood vessels rupture and cause bleeding in the brain. Patients with hemorrhagic stroke have a 1 in 10 risk each year of suffering 'major cardiovascular events' due to clotting (like a heart attack or stroke) or bleeding (like another brain hemorrhage). In a smaller study called RESTART, we showed that blood thinning drugs like aspirin seem to be safe and might benefit patients by reducing the risk of major cardiovascular events compared to staying off these drugs in 537 adults with hemorrhagic stroke. ASPIRING aims to confirm these findings in a much larger global trial of 4,148 patients, including 450 Canadians. Our team has worked with hemorrhagic stroke survivors to design ASPIRING. It will be a type of experiment known as a 'randomized controlled trial.' Randomized controlled trials are the most reliable tests of treatments. Patients with a hemorrhagic stroke that occurred at least 24 hours ago will be assigned at random, with a 50:50 chance of either receiving a blood thinning drug like aspirin or avoiding blood thinning drugs. We will follow patients for between one and five years until the study is finished. During this time they will be assessed by telephone every 6 months to monitor for new major cardiovascular events. The number of these events in each group will be monitored closely by a separate panel of doctors to ensure the safety of patients in the study. The study will finish once enough major cardiovascular events have occurred for us to be able to confidently detect whether using blood thinning drugs is better at preventing major cardiovascular events compared to staying off these drugs after hemorrhagic stroke. The results of ASPIRING will have the potential to substantially improve the health of the 250,000 people who survive a hemorrhagic stroke each year worldwide.