Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral haemorrhaGe (ASPIRING)-Pilot Phase

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Drug: Start antiplatelet monotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Start antiplatelet monotherapy (one antiplatelet drug available in local standard clinical practice, chosen by patient's physician pre-randomisation). | Drug: Start antiplatelet monotherapy<br>* Start one antiplatelet drug, be available in local standard clinical practice, chosen by patient's physician pre-randomisation<br>|
| No Intervention: Comparator<br>Avoid antiplatelet therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| regulatory approvals | Receipt of regulatory approvals in China，Australia and New Zealand separately, including Ethics, Human Genetics Resources Administration of China (HGRAC). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| trial database | Trial database structure and data flows that comply with data privacy and information governance regulations in China, Australia and New Zealand. | 6 months | 
| Site recruitment | Participation of 20 sites in China and 10 sites in Australia and New Zealand | 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. | 3 years | 
| Barriers to randomisation of eligible patients. | Barriers to randomisation of eligible patients. | 3 years | 
| Frequency of protocol deviations and violations. | Frequency of protocol deviations and violations. | 3 years | 
| Adherence to the allocated intervention by investigators and participants | Adherence to the allocated intervention by investigators and participants | 3 years | 
| Frequency of withdrawal and loss to follow-up | Frequency of withdrawal and loss to follow-up | 3 years | 
| Completeness of follow-up assessments | Completeness of follow-up assessments | 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. | 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) | 6 months | 
| Serious adverse event (SAE) | any serious adverse event (SAE) | at least 6 months | 
| Serious adverse reaction (SAR) | serious adverse reaction (SAR) | at least 6 months | 
| Suspected Unexpected Serious Adverse Reaction (SUSAR) | Suspected Unexpected Serious Adverse Reaction (SUSAR) | at least 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, intracerebral hemorrhage, antiplatelet therapy, aspirin, clopidogrel, cilostazol