Intracerebral HemorrhagePhase 3NCT04522102
Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral HaemorrhaGe (ASPIRING)-Pilot Phase
A Phase 3 study testing Start antiplatelet monotherapy in people with Intracerebral Hemorrhage, run by The George Institute for Global Health, China at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Start antiplatelet monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesChina
- Study dates
- 3 Sep 2021to 13 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The George Institute for Global Health
Beijing, Beijing Municipality, 100088
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
About this study
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
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.
Read the 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.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Start antiplatelet monotherapy
- Keywords
- stroke, intracerebral hemorrhage, antiplatelet therapy, aspirin, clopidogrel, cilostazol
- Medical subject headings
- Cerebral Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Start antiplatelet monotherapyDrug
Start one antiplatelet drug, be available in local standard clinical practice, chosen by patient's physician pre-randomisation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Start antiplatelet monotherapy (one antiplatelet drug available in local standard clinical practice, chosen by patient's physician pre-randomisation). Receives: Drug: Start antiplatelet monotherapy |
| Comparator | No intervention | Avoid antiplatelet therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
regulatory approvals
Receipt of regulatory approvals in China，Australia and New Zealand separately, including Ethics, Human Genetics Resources Administration of China (HGRAC).
Measured: 6 months
Secondary outcomes (13)
trial database
Trial database structure and data flows that comply with data privacy and information governance regulations in China, Australia and New Zealand.
Measured: 6 months
Site recruitment
Participation of 20 sites in China and 10 sites in Australia and New Zealand
Measured: 12-18 month
Calculate frequency of clinical data
Frequency of ICH survivors who are screened, eligible, approached, consented, and randomised by month and site from activation.
Measured: 3 years
Barriers to randomisation of eligible patients.
Barriers to randomisation of eligible patients.
Measured: 3 years
Frequency of protocol deviations and violations.
Frequency of protocol deviations and violations.
Measured: 3 years
Adherence to the allocated intervention by investigators and participants
Adherence to the allocated intervention by investigators and participants
Measured: 3 years
Frequency of withdrawal and loss to follow-up
Frequency of withdrawal and loss to follow-up
Measured: 3 years
Completeness of follow-up assessments
Completeness of follow-up assessments
Measured: 3 years
Characteristics of randomised participants compared with eligible patients who were not recruited.
Characteristics of randomised participants compared with eligible patients who were not recruited.
Measured: 3 years
Frequency of the composite of all serious vascular events
composite of all serious vascular events (non-fatal stroke, non-fatal myocardial infarction or death from a vascular cause)
Measured: 6 months
Serious adverse event (SAE)
any serious adverse event (SAE)
Measured: at least 6 months
Serious adverse reaction (SAR)
serious adverse reaction (SAR)
Measured: at least 6 months
Suspected Unexpected Serious Adverse Reaction (SUSAR)
Suspected Unexpected Serious Adverse Reaction (SUSAR)
Measured: at least 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start3 Sep 2021
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute for Global Health, China
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, Huashan Hospital, The University of Western Australia
- Responsible party
- Sponsor
- Investigators
- Rustam Al-Shahi Salman, Principal investigator, University of EdinburghCraig S Anderson, Principal investigator, The George InstituteGraeme Hankey, MD, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522102
- Sponsor's protocol ID
- ASPIRING
- Status last verified
- Mar 2025
- First submitted
- 18 Aug 2020
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.
PubMed 36700520Li 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.
PubMed 34022170Cheng 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.
PubMed 34022160
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04522102
- Acronym / sponsor ID
- ASPIRING
- Conditions
- Intracerebral Hemorrhage
- Keywords
- stroke, intracerebral hemorrhage, antiplatelet therapy, aspirin, clopidogrel, cilostazol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The George Institute for Global Health, ChinaUniversity, hospital or other
- Collaborators
- University of Edinburgh, Huashan Hospital, The University of Western Australia
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Start antiplatelet monotherapyStart antiplatelet monotherapy (one antiplatelet drug available in local standard clinical practice, chosen by patient's physician pre-randomisation). |
| Comparator | No intervention | –Avoid antiplatelet therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Start antiplatelet monotherapyStart one antiplatelet drug, be available in local standard clinical practice, chosen by patient's physician pre-randomisation | Drug | Intervention |
Primary outcome
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).
13 secondary outcomes
trial database
Time frame: 6 months
Site recruitment
Time frame: 12-18 month
Calculate frequency of clinical data
Time frame: 3 years
Barriers to randomisation of eligible patients.
Time frame: 3 years
Frequency of protocol deviations and violations.
Time frame: 3 years
Adherence to the allocated intervention by investigators and participants
Time frame: 3 years
Frequency of withdrawal and loss to follow-up
Time frame: 3 years
Completeness of follow-up assessments
Time frame: 3 years
Characteristics of randomised participants compared with eligible patients who were not recruited.
Time frame: 3 years
Frequency of the composite of all serious vascular events
Time frame: 6 months
Serious adverse event (SAE)
Time frame: at least 6 months
Serious adverse reaction (SAR)
Time frame: at least 6 months
Suspected Unexpected Serious Adverse Reaction (SUSAR)
Time frame: at least 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 36700520Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.
- Derived from this study: PubMed 34022170Li 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.
- Derived from this study: PubMed 34022160Cheng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rustam Al-Shahi Salman principal investigator
University of Edinburgh
Craig S Anderson principal investigator
The George Institute
Graeme Hankey, MD principal investigator
The University of Western Australia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Start antiplatelet monotherapy in people with Intracerebral Hemorrhage, run by The George Institute for Global Health, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regulatory approvals (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04522102, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.