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

Intracerebral Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04522102
• Other study ID #: ASPIRING
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 3, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: June 2023
• Source: The George Institute for Global Health, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

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

Locations

Country	Name	City	State
China	The George Institute for Global Health	Beijing	Beijing
China	Huashan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
The George Institute for Global Health, China	Huashan Hospital, The University of Western Australia, University of Edinburgh

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	regulatory approvals	Receipt of regulatory approvals in China,Australia and New Zealand separately, including Ethics, Human Genetics Resources Administration of China (HGRAC).	6 months
Secondary	trial database	Trial database structure and data flows that comply with data privacy and information governance regulations in China, Australia and New Zealand.	6 months
Secondary	Site recruitment	Participation of 20 sites in China and 10 sites in Australia and New Zealand	12-18 month
Secondary	Calculate frequency of clinical data	Frequency of ICH survivors who are screened, eligible, approached, consented, and randomised by month and site from activation.	3 years
Secondary	Barriers to randomisation of eligible patients.	Barriers to randomisation of eligible patients.	3 years
Secondary	Frequency of protocol deviations and violations.	Frequency of protocol deviations and violations.	3 years
Secondary	Adherence to the allocated intervention by investigators and participants	Adherence to the allocated intervention by investigators and participants	3 years
Secondary	Frequency of withdrawal and loss to follow-up	Frequency of withdrawal and loss to follow-up	3 years
Secondary	Completeness of follow-up assessments	Completeness of follow-up assessments	3 years
Secondary	Characteristics of randomised participants compared with eligible patients who were not recruited.	Characteristics of randomised participants compared with eligible patients who were not recruited.	3 years
Secondary	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)	6 months
Secondary	Serious adverse event (SAE)	any serious adverse event (SAE)	at least 6 months
Secondary	Serious adverse reaction (SAR)	serious adverse reaction (SAR)	at least 6 months
Secondary	Suspected Unexpected Serious Adverse Reaction (SUSAR)	Suspected Unexpected Serious Adverse Reaction (SUSAR)	at least 6 months