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Completed

NCT Number: NCT04522102

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The George Institute for Global Health, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Start antiplatelet monotherapy

Drug

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

Primary outcomes

  1. regulatory approvals

    Time frame: 6 months

    Receipt of regulatory approvals in China,Australia and New Zealand separately, including Ethics, Human Genetics Resources Administration of China (HGRAC).

Secondary outcomes

  1. trial database

    Time frame: 6 months

    Trial database structure and data flows that comply with data privacy and information governance regulations in China, Australia and New Zealand.

  2. Site recruitment

    Time frame: 12-18 month

    Participation of 20 sites in China and 10 sites in Australia and New Zealand

  3. Calculate frequency of clinical data

    Time frame: 3 years

    Frequency of ICH survivors who are screened, eligible, approached, consented, and randomised by month and site from activation.

  4. Barriers to randomisation of eligible patients.

    Time frame: 3 years

    Barriers to randomisation of eligible patients.

  5. Frequency of protocol deviations and violations.

    Time frame: 3 years

    Frequency of protocol deviations and violations.

  6. Adherence to the allocated intervention by investigators and participants

    Time frame: 3 years

    Adherence to the allocated intervention by investigators and participants

  7. Frequency of withdrawal and loss to follow-up

    Time frame: 3 years

    Frequency of withdrawal and loss to follow-up

  8. Completeness of follow-up assessments

    Time frame: 3 years

    Completeness of follow-up assessments

  9. Characteristics of randomised participants compared with eligible patients who were not recruited.

    Time frame: 3 years

    Characteristics of randomised participants compared with eligible patients who were not recruited.

  10. Frequency of the composite of all serious vascular events

    Time frame: 6 months

    composite of all serious vascular events (non-fatal stroke, non-fatal myocardial infarction or death from a vascular cause)

  11. Serious adverse event (SAE)

    Time frame: at least 6 months

    any serious adverse event (SAE)

  12. Serious adverse reaction (SAR)

    Time frame: at least 6 months

    serious adverse reaction (SAR)

  13. Suspected Unexpected Serious Adverse Reaction (SUSAR)

    Time frame: at least 6 months

    Suspected Unexpected Serious Adverse Reaction (SUSAR)

Sponsors and collaborators

Lead sponsor

The George Institute for Global Health, China

Other

Collaborators

  • Huashan Hospital
  • The University of Western Australia
  • University of Edinburgh

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2020
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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