Treatment Of Stroke reCurrence in Cerebral Amyloid Angiopathy with TraneXamic Acid (TOSCCAA- TXA)

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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624001477516

Acronym

TOSCCAA-TXA

Enrollment

Registered

2024-12-18

Start date

2025-06-25

Completion date

2027-01-31

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to assess the safety and feasibility of using tranexamic acid (TXA) in patients with cerebral amyloid angiopathy (CAA) and symptomatic brain bleeding to determine if TXA can reduce risk of recurrent intracranial haemorrhage without harmful side effects. We hypothesise TXA to be a safe and well tolerated treatment option for patients with CAA in reducing their risk of recurrent brain bleeding. Participants will be recruited from Alfred Health and Royal Melbourne Hospital, diagnosed with probable CAA, who have had previous brain bleeding within the last 6 months. They will be randomly assigned to take either 1 gram of TXA orally three times per day or an identical placebo for 6 months. All participants will have MRI scans with contrast and blood tests at the start and end of the study to measure biomarkers. Researchers will track participants' compliance with the treatment and any adverse events over the 6-month period. Primary outcomes will include feasibility measures (participation and adherence rates) and safety (monitoring for serious adverse events like clotting conditions, heart attacks, strokes, or death). Secondary outcomes will track the recurrence of various brain haemorrhages, progression of white matter changes, changes in cognitive function, and brain volume loss, as well as the development of new strokes.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Healthy volunteers

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

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

Outcome results