ASPIRING is an investigator-led, multicentre, prospective, randomised, open-label, blind outcome (PROBE), parallel group, clinical trial. The pilot phase will explore the feasibility of conducting a trial of starting antiplatelet monotherapy versus avoiding antiplatelet therapy for reducing all serious vascular events for adults surviving symptomatic stroke due to spontaneous intracerebral haemorrhage (ICH). The pilot phase will involve \~120 patients at \~30 hospitals in China, Australia and New Zealand.
The participant eligibility criteria specifically identify adults with history of symptomatic spontaneous ICH. Randomisation occurs if a participant and their doctor are uncertain about whether to start or avoid antiplatelet monotherapy at least 24 hours after ICH symptom onset. The intervention is a pragmatic policy of starting antiplatelet monotherapy (one antiplatelet drug available in local standard clinical practice, chosen by patient's physician pre-randomisation). The control group adopts a policy of avoiding antiplatelet therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
80
Start one antiplatelet drug, be available in local standard clinical practice, chosen by patient's physician pre-randomisation
The George Institute for Global Health
Beijing, Beijing Municipality, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
regulatory approvals
Receipt of regulatory approvals in China，Australia and New Zealand separately, including Ethics, Human Genetics Resources Administration of China (HGRAC).
Time frame: 6 months
trial database
Trial database structure and data flows that comply with data privacy and information governance regulations in China, Australia and New Zealand.
Time frame: 6 months
Site recruitment
Participation of 20 sites in China and 10 sites in Australia and New Zealand
Time frame: 12-18 month
Calculate frequency of clinical data
Frequency of ICH survivors who are screened, eligible, approached, consented, and randomised by month and site from activation.
Time frame: 3 years
Barriers to randomisation of eligible patients.
Barriers to randomisation of eligible patients.
Time frame: 3 years
Frequency of protocol deviations and violations.
Frequency of protocol deviations and violations.
Time frame: 3 years
Adherence to the allocated intervention by investigators and participants
Adherence to the allocated intervention by investigators and participants
Time frame: 3 years
Frequency of withdrawal and loss to follow-up
Frequency of withdrawal and loss to follow-up
Time frame: 3 years
Completeness of follow-up assessments
Completeness of follow-up assessments
Time frame: 3 years
Characteristics of randomised participants compared with eligible patients who were not recruited.
Characteristics of randomised participants compared with eligible patients who were not recruited.
Time frame: 3 years
Frequency of the composite of all serious vascular events
composite of all serious vascular events (non-fatal stroke, non-fatal myocardial infarction or death from a vascular cause)
Time frame: 6 months
Serious adverse event (SAE)
any serious adverse event (SAE)
Time frame: at least 6 months
Serious adverse reaction (SAR)
serious adverse reaction (SAR)
Time frame: at least 6 months
Suspected Unexpected Serious Adverse Reaction (SUSAR)
Suspected Unexpected Serious Adverse Reaction (SUSAR)
Time frame: at least 6 months
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