Antiplatelet Secondary Prevention International Randomised study after INtracerebral haemorrhaGe
Background: Survivors of stroke due to spontaneous intracerebral haemorrhage (ICH) are at high risk of further major adverse cardiovascular or cerebrovascular events (MACE). In the REstart or STop Antithrombotics Randomised Trial (RESTART, www.RESTARTtrial.org), starting antiplatelet therapy after ICH was safe and seemed to reduce the risk of MACE (Lancet 2019). An external pilot phase of ASPIRING (NCT04522102) confirmed feasibility of recruiting in Australia.
Aims: To provide definitive evidence of the superiority of starting antiplatelet monotherapy versus avoiding antiplatelet agents (in addition to standard care) to prevent MACE for ICH survivors.
Setting: UK, Canada, The Netherlands, Australia, Belgium, 2025-2029
Design: Randomised, open-label, clinical trial
Participants: Adults aged ≥18 years, who survive ≥24 hours after symptomatic ICH onset, with or without a history of vascular disease symptoms or risk factors, who have not taken antithrombotic therapy within the preceding 24 hours.
Randomisation: Central, computerised
Intervention: Start or avoid antiplatelet monotherapy (with aspirin or clopidogrel, investigators choice).
Follow-up: At hospital discharge or 30±5 days after randomisation (whichever is earliest) by site investigator. At 3 months, 6 months, & 6 monthly thereafter to 2029 – remotely, by the Central Trial Office in Perth.
Primary outcome: MACE (vascular death or hospitalisation due to non-fatal stroke or non-fatal myocardial infarction) for 1-5 years.
Sample size: 4,148 patients globally, 330 from 12-15 sites in Australia.
Sponsor: Global Co-sponsor: The University of Edinburgh & Lothian Health Board, ACCORD. Australia: Sir Charles Gairdner and Osborne Park Health Care Group
Budget:
$ 1,000 per patient with completed data at hospital discharge or 30±5 days after randomisation.
Website: http://ASPIRING.ed.ac.uk.
