Lacunar Intervention Trials (LACI-1, LACI-2)

The Row Fogo Centre has led the way with the Lacunar Intervention Trials (LACI-1, LACI-2) randomised controlled trials testing two repurposed drugs, cilostazol and isosorbide mononitrate (ISMN), to prevent worsening of SVD.

There are medications commonly used for other vascular conditions that may hold the potential to enhance small vessel function and prevent further vascular brain damage.

LACI-1 tested whether a much larger scale study testing the effects of cilostazol and ISMN on preventing brain damage from Small Vessel Disease would be feasible. The team found that cilostazol and ISMN are well tolerated when the dose is escalated, without safety concerns, in patients with lacunar stroke. These findings led the way for LACI-2, a larger trial with a longer follow-up period.

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Following LACI-1, the researchers wanted to test whether the study methods were practical so that patients and trial centres could follow the procedures for up to a year. The LACI-2 team also needed to establish how many patients developed recurrent stroke or had a decline in their cognitive abilities.

The results indicate that the LACI-2 trial was practical, and ISMN and cilostazol were well-tolerated and safe. These medications have the potential to decrease the risk of recurrent stroke, dependence, and cognitive decline following a lacunar (small vessel) stroke, and they may also mitigate other adverse effects of SVD.

This information is key to staging a much larger clinical trial, LACI-3, to find out if these drugs can prevent worsening of Small Vessel Disease in patients with lacunar ischaemic stroke, and testing in cognitive, covert, and other stroke presentations of SVD.