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

The George Institute for Global Health, China

Status and phase: Completed; Phase 3

Conditions: Intracerebral Hemorrhage

Treatments: Drug: Start antiplatelet monotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04522102

ASPIRING

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Intervention

Experimental group

Description:

Start antiplatelet monotherapy (one antiplatelet drug available in local standard clinical practice, chosen by patient's physician pre-randomisation).

Treatment:

Drug: Start antiplatelet monotherapy

Comparator

No Intervention group

Description:

Avoid antiplatelet therapy.