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

Primary Purpose

Intracerebral Hemorrhage

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Start antiplatelet monotherapy

About this trial

This is an interventional prevention trial for Intracerebral Hemorrhage focused on measuring stroke, intracerebral hemorrhage, antiplatelet therapy, aspirin, clopidogrel, cilostazol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The George Institute for Global Health
Huashan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Comparator

Arm Description

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

Avoid antiplatelet therapy.

Outcomes

Primary Outcome Measures

regulatory approvals

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

Secondary Outcome Measures

trial database

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

Site recruitment

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

Calculate frequency of clinical data

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

Barriers to randomisation of eligible patients.

Frequency of protocol deviations and violations.

Adherence to the allocated intervention by investigators and participants

Frequency of withdrawal and loss to follow-up

Completeness of follow-up assessments

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

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)

Serious adverse event (SAE)

any serious adverse event (SAE)

Serious adverse reaction (SAR)

serious adverse reaction (SAR)

Suspected Unexpected Serious Adverse Reaction (SUSAR)

Full Information

NCT ID

NCT04522102

First Posted

August 18, 2020

Last Updated

June 13, 2023

Sponsor

The George Institute for Global Health, China

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04522102

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 3, 2021 (Actual)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The George Institute for Global Health, China

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracerebral Hemorrhage

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Comparator

Arm Type

No Intervention

Arm Description

Avoid antiplatelet therapy.

Intervention Type

Drug

Intervention Name(s)

Start antiplatelet monotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

regulatory approvals

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

trial database

Description

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

Time Frame

6 months

Title

Site recruitment

Description

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

Time Frame

12-18 month

Title

Calculate frequency of clinical data

Description

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

Time Frame

3 years

Title

Barriers to randomisation of eligible patients.

Description

Barriers to randomisation of eligible patients.

Time Frame

3 years

Title

Frequency of protocol deviations and violations.

Description

Frequency of protocol deviations and violations.

Time Frame

3 years

Title

Adherence to the allocated intervention by investigators and participants

Description

Adherence to the allocated intervention by investigators and participants

Time Frame

3 years

Title

Frequency of withdrawal and loss to follow-up

Description

Frequency of withdrawal and loss to follow-up

Time Frame

3 years

Title

Completeness of follow-up assessments

Description

Completeness of follow-up assessments

Time Frame

3 years

Title

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

Description

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

Time Frame

3 years

Title

Frequency of the composite of all serious vascular events

Description

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

Time Frame

6 months

Title

Serious adverse event (SAE)

Description

any serious adverse event (SAE)

Time Frame

at least 6 months

Title

Serious adverse reaction (SAR)

Description

serious adverse reaction (SAR)

Time Frame

at least 6 months

Title

Suspected Unexpected Serious Adverse Reaction (SUSAR)

Description

Suspected Unexpected Serious Adverse Reaction (SUSAR)

Time Frame

at least 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rustam Al-Shahi Salman

Organizational Affiliation

University of Edinburgh

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Craig S Anderson

Organizational Affiliation

The George Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Graeme Hankey, MD

Organizational Affiliation

The University of Western Australia

Official's Role

Principal Investigator

Facility Information:

Facility Name

The George Institute for Global Health

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100088

Country

China

Facility Name

Huashan Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200000

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

34022170

Citation

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 Jun 9;:

Results Reference

derived

PubMed Identifier

34022160

Citation

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.

Results Reference

derived

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

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