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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The George Institute for Global Health, China
• Collaborators: Huashan Hospital; The University of Western Australia; University of Edinburgh

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.