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

NCT04522102 | Completed Phase 3 DMC

• 1 other identifier: ASPIRING
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Intracerebral Hemorrhage

Keywords

stroke; intracerebral hemorrhage; antiplatelet therapy; aspirin; clopidogrel; cilostazol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• trial database

  6 months

• Site recruitment

  12-18 month

• Calculate frequency of clinical data

  3 years

• Barriers to randomisation of eligible patients.

  3 years

• Frequency of protocol deviations and violations.

  3 years

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: Start antiplatelet monotherapy

Comparator

NO INTERVENTION

Avoid antiplatelet therapy.

Interventions

Start antiplatelet monotherapy DRUG

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The George Institute for Global Health, China: lead
• University of Edinburgh: collaborator
• Huashan Hospital: collaborator
• The University of Western Australia: collaborator

Study Sites (2)

The George Institute for Global Health

Beijing, Beijing Municipality, 100088, China

Location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (3)

• 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.

  PMID: 36700520 DERIVED

• 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.

  PMID: 34022170 DERIVED

• 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.

  PMID: 34022160 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: September 3, 2021
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)