NCT04522102.

Study name	Antiplatelet Secondary Prevention International Randomised trial after INtracerebral haemorrhaGe (ASPIRING) ‐ pilot phase
Methods	Design: randomised controlled PROBE parallel group trial Setting: multicentre hospital sites in China and Australia Dates: September 2021 to June 2023
Participants	Sample size: 120 participants Diagnosis: ICH Inclusion criteria Patient age ≥ 18 years Symptomatic stroke due to spontaneous (non‐traumatic) ICH Patient is at least 24 hours after ICH symptom onset Patient and their doctor are both uncertain about whether to start or avoid antiplatelet monotherapy Consent to randomisation from the patient (or personal/legal/professional representative if the patient does not have mental capacity) Exclusion criteria ICH due to head injury, in the opinion of the investigator ICH due to haemorrhagic transformation of an ischaemic stroke, in the opinion of the investigator Patient is already taking antiplatelet therapy, or full dose anticoagulant therapy, after ICH Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception Patient and carer unable to understand spoken or written local language
Interventions	Intervention: start antiplatelet monotherapy (one antiplatelet drug available in local standard clinical practice, chosen by patient's physician pre‐randomisation) Comparator: avoid antiplatelet therapy
Outcomes	Primary outcome Receipt of regulatory approvals in China, Australia and New Zealand separately, including Ethics, Human Genetics Resources Administration of China (HGRAC) Secondary outcomes Trial database structure and data flows that comply with data privacy and information governance regulations in China, Australia and New Zealand Participation of 20 sites in China and 10 sites in Australia and New Zealand Frequency of ICH survivors who are screened, eligible, approached, consented, and randomised by month and site from activation Barriers to randomisation of eligible patients Frequency of protocol deviations and violations Adherence to the allocated intervention by investigators and participants Frequency of withdrawal and loss to follow‐up Completeness of follow‐up assessments Characteristics of randomised participants compared with eligible patients who were not recruited Composite of all serious vascular events (non‐fatal stroke, non‐fatal myocardial infarction or death from a vascular cause) Any serious adverse event Any serious adverse reaction Suspected unexpected serious adverse reactions Duration of follow‐up: up to 3 years
Starting date	3 September 2021
Contact information	Rustam AI‐Shahi Salman, +44 131 242 7014, Rustam.Al-Shahi@ed.ac.uk Lily Song, +86 13916466400, lsong@georgeinstitute.org.cn
Notes	Declarations of interest: not specified in trials register Sources of funding: not specified in trials register