RecruitingPhase 2ACTRN12624001477516

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.

Sponsor

Alfred Health

Enrollment

60 participants

Start Date

Jun 25, 2025

Study Type

Interventional

Conditions

Cerebral Amyloid Angiopathy

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.

Eligibility

Sex: Both males and femalesMin Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

Cerebral amyloid angiopathy (CAA) is a condition where a protein called amyloid builds up in the walls of blood vessels in the brain, making them fragile and prone to bleeding. People with CAA have a significantly elevated risk of recurrent brain bleeds (intracranial haemorrhages), which can be life-altering or fatal. Currently, there are very few treatment options available to reduce this risk. This study (called TOSCCAA-TXA) is testing whether tranexamic acid (TXA) — a medication commonly used to reduce bleeding in surgery — is safe and well-tolerated when used in patients with CAA who have had a recent brain bleed. Participants will take either 1 gram of TXA three times daily or a matching placebo for six months, and will have MRI scans and blood tests at the start and end to track changes. The study is focused primarily on safety and feasibility at this stage. You may be eligible if you are aged 50 or older, have a diagnosis of probable CAA based on standard criteria, have had a symptomatic brain bleed in the past six months, and are able to have MRI scans. People with significant kidney impairment, epilepsy, a recent heart attack or blood clot, or who are unable to provide consent would not be eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 specific