Intracerebral Hemorrhage
Conditions
Keywords
stroke, intracerebral hemorrhage, antiplatelet therapy, aspirin, clopidogrel, cilostazol
Brief summary
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.
Detailed description
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.
Interventions
DRUGStart antiplatelet monotherapy
Start one antiplatelet drug, be available in local standard clinical practice, chosen by patient's physician pre-randomisation
Sponsors
The George Institute for Global Health, China
University of Edinburgh
Huashan Hospital
The University of Western Australia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient age ≥18 years. 2. Symptomatic stroke due to spontaneous (non-traumatic) ICH. 3. Patient is at least 24 hours after ICH symptom onset. 4. Patient and their doctor are both uncertain about whether to start or avoid antiplatelet monotherapy. 5. Consent to randomisation from the patient (or personal / legal / professional representative if the patient does not have mental capacity).
Exclusion criteria
1. ICH due to head injury, in the opinion of the investigator. 2. ICH due to haemorrhagic transformation of an ischaemic stroke, in the opinion of the investigator. 3. Patient is already taking antiplatelet therapy, or full dose anticoagulant therapy, after ICH. 4. Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception. 5. Patient and carer unable to understand spoken or written local language.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| regulatory approvals | 6 months | Receipt of regulatory approvals in China，Australia and New Zealand separately, including Ethics, Human Genetics Resources Administration of China (HGRAC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Site recruitment | 12-18 month | Participation of 20 sites in China and 10 sites in Australia and New Zealand |
| Calculate frequency of clinical data | 3 years | Frequency of ICH survivors who are screened, eligible, approached, consented, and randomised by month and site from activation. |
| Barriers to randomisation of eligible patients. | 3 years | Barriers to randomisation of eligible patients. |
| Frequency of protocol deviations and violations. | 3 years | Frequency of protocol deviations and violations. |
| Adherence to the allocated intervention by investigators and participants | 3 years | Adherence to the allocated intervention by investigators and participants |
| Frequency of withdrawal and loss to follow-up | 3 years | Frequency of withdrawal and loss to follow-up |
| trial database | 6 months | Trial database structure and data flows that comply with data privacy and information governance regulations in China, Australia and New Zealand. |
| Characteristics of randomised participants compared with eligible patients who were not recruited. | 3 years | Characteristics of randomised participants compared with eligible patients who were not recruited. |
| Frequency of the composite of all serious vascular events | 6 months | composite of all serious vascular events (non-fatal stroke, non-fatal myocardial infarction or death from a vascular cause) |
| Serious adverse event (SAE) | at least 6 months | any serious adverse event (SAE) |
| Serious adverse reaction (SAR) | at least 6 months | serious adverse reaction (SAR) |
| Suspected Unexpected Serious Adverse Reaction (SUSAR) | at least 6 months | Suspected Unexpected Serious Adverse Reaction (SUSAR) |
| Completeness of follow-up assessments | 3 years | Completeness of follow-up assessments |
Countries
China
Outcome results
None listed