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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-03

Study Completion Date

2023-10-13

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.

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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.

Conditions

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Intracerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Start antiplatelet monotherapy

Intervention Type DRUG

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

Comparator

Avoid antiplatelet therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Start antiplatelet monotherapy

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No