Start antiplatelet monotherapy
DrugStart one antiplatelet drug, be available in local standard clinical practice, chosen by patient's physician pre-randomisation
NCT Number: NCT04522102
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
The George Institute for Global Health, Beijing, Beijing Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Start one antiplatelet drug, be available in local standard clinical practice, chosen by patient's physician pre-randomisation
Time frame: 6 months
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 structure and data flows that comply with data privacy and information governance regulations in China, Australia and New Zealand.
Time frame: 12-18 month
Participation of 20 sites in China and 10 sites in Australia and New Zealand
Time frame: 3 years
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.
Time frame: 3 years
Frequency of protocol deviations and violations.
Time frame: 3 years
Adherence to the allocated intervention by investigators and participants
Time frame: 3 years
Frequency of withdrawal and loss to follow-up
Time frame: 3 years
Completeness of follow-up assessments
Time frame: 3 years
Characteristics of randomised participants compared with eligible patients who were not recruited.
Time frame: 6 months
composite of all serious vascular events (non-fatal stroke, non-fatal myocardial infarction or death from a vascular cause)
Time frame: at least 6 months
any serious adverse event (SAE)
Time frame: at least 6 months
serious adverse reaction (SAR)
Time frame: at least 6 months
Suspected Unexpected Serious Adverse Reaction (SUSAR)
The George Institute for Global Health, China
Other
An Investigator Initiated and Conducted, Prospective, Multicentre, Randomised Outcome-blinded Pilot Study of Antiplatelet Therapy in Patients with a History of Stroke Due to Intracerebral Haemorrhage
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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