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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04522102




Registration number
NCT04522102
Ethics application status
Date submitted
18/08/2020
Date registered
21/08/2020
Date last updated
15/06/2023

Titles & IDs
Public title
Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral haemorrhaGe (ASPIRING)-Pilot Phase
Scientific 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
Secondary ID [1] 0 0
ASPIRING
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Start antiplatelet monotherapy

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

No Intervention: Comparator - Avoid antiplatelet therapy.


Treatment: Drugs: Start antiplatelet monotherapy
Start one antiplatelet drug, be available in local standard clinical practice, chosen by patient's physician pre-randomisation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
regulatory approvals
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
trial database
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Site recruitment
Timepoint [2] 0 0
12-18 month
Secondary outcome [3] 0 0
Calculate frequency of clinical data
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Barriers to randomisation of eligible patients.
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Frequency of protocol deviations and violations.
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
Adherence to the allocated intervention by investigators and participants
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Frequency of withdrawal and loss to follow-up
Timepoint [7] 0 0
3 years
Secondary outcome [8] 0 0
Completeness of follow-up assessments
Timepoint [8] 0 0
3 years
Secondary outcome [9] 0 0
Characteristics of randomised participants compared with eligible patients who were not recruited.
Timepoint [9] 0 0
3 years
Secondary outcome [10] 0 0
Frequency of the composite of all serious vascular events
Timepoint [10] 0 0
6 months
Secondary outcome [11] 0 0
Serious adverse event (SAE)
Timepoint [11] 0 0
at least 6 months
Secondary outcome [12] 0 0
Serious adverse reaction (SAR)
Timepoint [12] 0 0
at least 6 months
Secondary outcome [13] 0 0
Suspected Unexpected Serious Adverse Reaction (SUSAR)
Timepoint [13] 0 0
at least 6 months

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2023
Actual
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Shanghai

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute for Global Health, China
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04522102
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Rustam Al-Shahi Salman
Address 0 0
University of Edinburgh
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04522102