21 Apr 20. Featured Paper
Protocol: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease.
Joanna Wardlaw, Philip M W Bath, Fergus Doubal, Anna Heye, Nikola Sprigg, Lisa J Woodhouse, Gordon Blair, Jason Appleton, Vera Cvoro, Timothy England, Ahamad Hassan, David John Werring, Alan Montgomery, The LACI-2 Trial Investigators
However, there is no specific treatment to prevent progression of small vessel disease.
Aim: We designed the LACunar Intervention Trial-2 (LACI-2) to test feasibility of a large trial testing cilostazol &/or isosorbide mononitrate (ISMN) by demonstrating adequate participant recruitment & retention in follow-up, drug tolerability, safety & confirm outcome event rates required to power a phase 3 trial.
Methods & design: LACI-2 is an investigator-initiated, prospective randomised open label blinded endpoint (PROBE) trial aiming to recruit 400 patients with prior lacunar syndrome due to a small subcortical infarct.
We randomise participants to cilostazol v no cilostazol & ISMN or no ISMN, minimising on key prognostic factors.
All patients receive guideline-based best medical therapy.
Patients commence trial drug at low dose, increment to full dose over 2–4 weeks, continuing on full dose for a year.
We follow-up participants to one year for symptoms, tablet compliance, safety, recurrent vascular events, cognition & functional outcomes, Trails B & brain MRI. LACI-2 is registered ISRCTN 14911850, EudraCT 2016–002277-35.
Trial outcome: Primary outcome is feasibility of recruitment & compliance; secondary outcomes include safety (cerebral or systemic bleeding, falls, death), efficacy (recurrent cerebral & cardiac vascular events, cognition on TICS, Trails B) & tolerability.
- Isosorbide mononitrate
- Lacunar stroke
- Randomised clinical trial
- Small vessel disease (SVD)