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Trial registered on ANZCTR


Registration number
ACTRN12624001477516
Ethics application status
Approved
Date submitted
15/10/2024
Date registered
18/12/2024
Date last updated
18/12/2024
Date data sharing statement initially provided
18/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment Of Stroke reCurrence in Cerebral Amyloid Angiopathy with TraneXamic Acid (TOSCCAA- TXA)
Scientific title
A Phase 2 double blinded randomised controlled clinical trial assessing the safety and feasibility of Tranexamic Acid for prevention of recurrent intracranial haemorrhage in adults with probable Cerebral Amyloid Angiopathy.
Secondary ID [1] 312935 0
none
Universal Trial Number (UTN)
Trial acronym
TOSCCAA-TXA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Amyloid Angiopathy 335101 0
Condition category
Condition code
Stroke 331603 331603 0 0
Haemorrhagic
Neurological 332117 332117 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tranexamic acid (INN: 2060) 1g, given as 2x 500mg tablets orally administered three times per day for 6 months. Adherence assessed on follow up visits with tablet count and questions designed specifically for this study.
Intervention code [1] 329466 0
Treatment: Drugs
Comparator / control treatment
Compared to identical placebo tablets taken 1g (2x 500mg) orally administered three times per day for 6 months. Composition: PROSOLV® EASYtab SP, which contains microcrystalline Cellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 339340 0
Feasibility- This will be assessed as a composite outcome
Timepoint [1] 339340 0
All parameters will be assessed at baseline and at 6 months (completion of intervention)
Primary outcome [2] 339341 0
Safety- This will be assessed as a composite outcome
Timepoint [2] 339341 0
Outcome measured at 6 months (completion of intervention)
Secondary outcome [1] 439582 0
Efficacy as measured by Symptomatic spontaneous Intracerebral Haemorrhage (sICH) or convexity Sub-Arachnoid Haemorrhage (cSAH) at 6 and 12 months
Timepoint [1] 439582 0
6 months (completion of intervention) and 12 months (final follow up)
Secondary outcome [2] 439583 0
Incidence of all hemorrhagic lesions and sub-categories (ICH, cSAH, cerebral microbleeds (CMBs), superficial siderosis) as a composite outcome on brain MRI over 6 months
Timepoint [2] 439583 0
6 months (completion of intervention)
Secondary outcome [3] 441292 0
Progression of white matter hyperintensities on MRI at 6 months
Timepoint [3] 441292 0
6 months (completion of intervention)
Secondary outcome [4] 441293 0
The prevalence and incidence of contrast enhancement of the leptomeninges, brain parenchyma and cortical small vessel walls assessed as a composite outcome.
Timepoint [4] 441293 0
6 months (completion of intervention)
Secondary outcome [5] 441294 0
Progression of cerebral volume loss over 6 months
Timepoint [5] 441294 0
6 months (completion of intervention)
Secondary outcome [6] 441295 0
Change in cognitive assessment scores at 6 months
Timepoint [6] 441295 0
6 months (completion of intervention)
Secondary outcome [7] 442089 0
Ordinal shift in mRS from baseline to 6 months and 12 months
Timepoint [7] 442089 0
Measured at 6 months (completion of intervention) and 12 months (final follow up)
Secondary outcome [8] 442090 0
Safety: Rate of development of any ischaemic brain injury and subcategories (DWI+ lesions, lacunes, cortical infarcts) as a composite outcome over 6 months.
Timepoint [8] 442090 0
6 months (completion of intervention)

Eligibility
Key inclusion criteria
• Diagnosis of probable CAA by modified Boston Criteria 2.0 with recent symptomatic intracranial bleeding (ICH, cSAH, or both) within 6 months prior to randomisation
• At least 2 or more of the following strictly lobar haemorrhagic lesions on T2*-weighted MRI, in any combination: ICH, CMB, cSS/cSAH foci
•Able to have MRI at baseline and 6 month follow-up
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to have MRI or any contraindications to MRI
• Renal impairment (eGFR < 30 mls/min/1.73m2)
• Epilepsy
• Known fibrinolytic condition
• History of unprovoked venous thromboembolism (VTE) (e.g. deep vein thrombosis (DVT), pulmonary embolism PE), Cerebral Venous Sinus thrombosis (CVST)) within 12 months of randomisation
• History of haematuria or renal parenchymal disease
• Myocardial infarction (MI) within 12 months of randomisation
• Functionally dependent (score of >3 on the modified Rankin scale)
• Unable to provide informed consent

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)
allocation concealment by central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/04/2025
Actual
Date of last participant enrolment
Anticipated
14/10/2026
Actual
Date of last data collection
Anticipated
14/10/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317370 0
Hospital
Name [1] 317370 0
Alfred Health
Country [1] 317370 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Country
Australia
Secondary sponsor category [1] 319658 0
None
Name [1] 319658 0
Address [1] 319658 0
Country [1] 319658 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316099 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316099 0
Ethics committee country [1] 316099 0
Australia
Date submitted for ethics approval [1] 316099 0
28/10/2024
Approval date [1] 316099 0
02/12/2024
Ethics approval number [1] 316099 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136774 0
Prof Geoffrey Cloud
Address 136774 0
Alfred health, 55 Commercial Rd, Melbourne VIC 3004
Country 136774 0
Australia
Phone 136774 0
+613 9076 2552
Fax 136774 0
Email 136774 0
g.cloud@alfred.org.au
Contact person for public queries
Name 136775 0
Rachael Castine (Personal Assistant – Professor Geoffrey Cloud)
Address 136775 0
Alfred health, 55 Commercial Rd, Melbourne VIC 3004
Country 136775 0
Australia
Phone 136775 0
+613 9903 0900
Fax 136775 0
Email 136775 0
r.castine@alfred.org.au
Contact person for scientific queries
Name 136776 0
Geoffrey Cloud
Address 136776 0
Alfred health, 55 Commercial Rd, Melbourne VIC 3004
Country 136776 0
Australia
Phone 136776 0
+613 9076 2552
Fax 136776 0
Email 136776 0
g.cloud@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.