Clinical trial NCT04522102: Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral HaemorrhaGe (ASPIRING)-Pilot Phase
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intracerebral Hemorrhage
Keywords: stroke
intracerebral hemorrhage
antiplatelet therapy
aspirin
clopidogrel
cilostazol
Lead sponsor: The George Institute for Global Health, China
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
name: Huashan Hospital
name: The University of Western Australia
First posted: 2020-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: regulatory approvals
timeFrame: 6 months
Secondary outcomes:
measure: trial database
timeFrame: 6 months
measure: Site recruitment
timeFrame: 12-18 month
measure: Calculate frequency of clinical data
timeFrame: 3 years
measure: Barriers to randomisation of eligible patients.
timeFrame: 3 years
measure: Frequency of protocol deviations and violations.
timeFrame: 3 years
measure: Adherence to the allocated intervention by investigators and participants
timeFrame: 3 years
measure: Frequency of withdrawal and loss to follow-up
timeFrame: 3 years
measure: Completeness of follow-up assessments
timeFrame: 3 years
measure: Characteristics of randomised participants compared with eligible patients who were not recruited.
timeFrame: 3 years
measure: Frequency of the composite of all serious vascular events
timeFrame: 6 months
measure: Serious adverse event (SAE)
timeFrame: at least 6 months
measure: Serious adverse reaction (SAR)
timeFrame: at least 6 months
measure: Suspected Unexpected Serious Adverse Reaction (SUSAR)
timeFrame: at least 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: The George Institute for Global Health
state: Beijing
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: University of Edinburgh
name: Rustam Al-Shahi Salman
role: PRINCIPAL_INVESTIGATOR
affiliation: The George Institute
name: Craig S Anderson
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Western Australia
name: Graeme Hankey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li L, Poon MTC, Samarasekera NE, Perry LA, Moullaali TJ, Rodrigues MA, Loan JJM, Stephen J, Lerpiniere C, Tuna MA, Gutnikov SA, Kuker W, Silver LE, Al-Shahi Salman R, Rothwell PM. Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies. Lancet Neurol. 2021 Jun;20(6):437-447. doi: 10.1016/S1474-4422(21)00075-2.
citation: Cheng X, Dong Q. Towards individualised secondary prevention after intracerebral haemorrhage. Lancet Neurol. 2021 Jun;20(6):411-413. doi: 10.1016/S1474-4422(21)00130-7. No abstract available.