Trial Information

LACI-3 is a phase III trial which will evaluate the long-term effects of cilostazol and isosorbide mononitrate (ISMN) in preventing adverse outcomes following lacunar stroke and progression of cerebral small vessel disease (SVD).

In the LACI-2 trial, which included 363 of the planned 400 patients, we found that recruitment, assessment, and retention were feasible. Both drugs were well tolerated, individually and in combination, showing potential benefits on recurrent stroke, cognition, quality of life (QoL), and dependency. These results support the progression to the LACI-3 trial.

LACI-3 will include independent patients over 30 with recent lacunar ischaemic stroke or other SVD features. Exclusions include contraindications to cilostazol or ISMN, pregnancy, non-SVD stroke mechanisms, dementia, dependency, and other active neurological or long-term diseases.

Baseline assessments will cover demographics, medical history, cognition, mood, and brain imaging (CT preferred, or MRI with specific sequences). Randomization (1:1:1:1) will allocate patients to cilostazol, ISMN, both, or neither, on top of standard stroke prevention treatments.

Follow-up will occur at six and 12 months, then annually, averaging two years. Assessments will include cognition, dependency, recurrent stroke, vascular events, mood, physical ability, drug compliance, adverse events, and quality of life. Recurrent strokes and other serious events will be reported as they occur, with informant contact for cognitive assessments where possible.