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

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.

Study Overview

• Status: Completed
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Drug: Start antiplatelet monotherapy

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100088
      • The George Institute for Global Health
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Huashan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Start antiplatelet monotherapy (one antiplatelet drug available in local standard clinical practice, chosen by patient's physician pre-randomisation).	Drug: Start antiplatelet monotherapy; Start one antiplatelet drug, be available in local standard clinical practice, chosen by patient's physician pre-randomisation
No Intervention: Comparator; Avoid antiplatelet therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Site recruitment	Participation of 20 sites in China and 10 sites in Australia and New Zealand	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.	3 years
Barriers to randomisation of eligible patients.	Barriers to randomisation of eligible patients.	3 years
Frequency of protocol deviations and violations.	Frequency of protocol deviations and violations.	3 years
Adherence to the allocated intervention by investigators and participants	Adherence to the allocated intervention by investigators and participants	3 years
Frequency of withdrawal and loss to follow-up	Frequency of withdrawal and loss to follow-up	3 years
Completeness of follow-up assessments	Completeness of follow-up assessments	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.	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)	6 months
Serious adverse event (SAE)	any serious adverse event (SAE)	at least 6 months
Serious adverse reaction (SAR)	serious adverse reaction (SAR)	at least 6 months
Suspected Unexpected Serious Adverse Reaction (SUSAR)	Suspected Unexpected Serious Adverse Reaction (SUSAR)	at least 6 months

Collaborators and Investigators

• Sponsor: The George Institute for Global Health, China
• Collaborators: Huashan Hospital; University of Edinburgh; The University of Western Australia
• Investigators: Principal Investigator: Rustam Al-Shahi Salman, University of Edinburgh; Principal Investigator: Craig S Anderson, The George Institute; Principal Investigator: Graeme Hankey, MD, The University of Western Australia

Publications and helpful links

General Publications

• Cheng 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.
• Li 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. Erratum In: Lancet Neurol. 2021 Aug;20(8):e5. doi: 10.1016/S1474-4422(21)00185-X.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Actual): October 13, 2023
• Study Completion (Actual): October 13, 2023

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 22, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: stroke; intracerebral hemorrhage; clopidogrel; aspirin; cilostazol; antiplatelet therapy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: ASPIRING

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No