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. 2022 Jul 13;2022(7):CD012269. doi: 10.1002/14651858.CD012269.pub2

LACI‐2.

Study name LACunar Intervention (LACI‐2) Trial‐2: assessment of safety and efficacy of cilostazol and isosorbide mononitrate to prevent recurrent lacunar stroke and progression of cerebral small vessel disease 
Methods Phase 2b preparatory to phase 3 randomised, partial factorial, open‐label, blinded endpoint trial 
Participants 400
Interventions Isosorbide mononitrate oral titrated dosing 
Cilostazol oral titrated dosing 
Isosorbide mononitrate + cilostazol
Outcomes
  1. Dose‐specific trial medication tolerability (over 36 months)

  2. Incidence of treatment emergent adverse effects (safety) over 36 months

  3. Treatment efficacy: rate of individual participant events (stroke, TIA, myocardial ischaemia, cognitive impairment and dementia) over 36 months

Starting date 2018
Contact information Chief Investigator: Joanna M Wardlaw, University of Edinburgh, UK
Notes