Background: Cerebral small vessel disease (SVD) causes lacunar strokes (25% of all ischaemic strokes), physical frailty and cognitive impairment and vascular and mixed dementia. There is no specific treatment to prevent progression of SVD. Methods: The LACunar Intervention Trial-2 (LACI-2) is an investigator-initiated prospective randomised open-label blinded-endpoint (PROBE) phase II feasibility study assessing cilostazol and isosorbide mononitrate for preventing SVD progression. We aimed to recruit 400 patients with clinically-evident lacunar ischaemic stroke and randomised to cilostazol, isosorbide mononitrate, both or neither, in addition to guideline secondary ischaemic stroke prevention, in a partial factorial design. The primary outcome is feasibility of recruitment and adherence to medication; key secondary outcomes include: drug tolerability; recurrent vascular events, cognition and function at one year after randomisation; and safety (bleeding, falls, death). Data are number (%), and median [interquartile range]. Results: The trial commenced on 5th of February 2018 and ceased recruitment on 31st of May 2021 with 363 patients randomised, with the following baseline characteristics: average age 64 [56.0, 72.0] years, female 112 (30.9%), stroke onset to randomisation 79.0 [27.0, 244.0] days, hypertension 267 (73.6%), median blood pressures 143.0 [130.0, 157.0]/83.0 [75.0, 90.0] mmHg, current smokers 67 (18.5%), educationally achieved end of school examinations (A-level) or higher 118 (32.5%), modified Rankin scale 1.0 [0.0, 1.0], National Institutes Health stroke scale (NIHSS) 1.0 (1.4), Montreal Cognitive Assessment 26.0 [23.0, 28.0] and total SVD score on brain imaging 1.0 [0.0, 2.0]. This publication summarises the baseline data and presents the statistical analysis plan. Summary The trial is currently in follow-up which will complete on 31 May 2022 with results expected in October 2022.

The authors received funding for the research, as described under funding.

ISRCTN: ISRCTN14911850

https://pubmed.ncbi.nlm.nih.gov/33072884/

This study was funded by the British Heart Foundation (CS/15/5/31475); the Alzheimers Society (AS PG 14 033); EU Horizon 2020 SVDs Target (666881) MRC UK DRI, Fondation Leducq (16/05 CVD); NHS Research Scotland; The Stroke Association and Garfield-Weston Foundation, Chief Scientist Office (UC); and National Institute of Health Research.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

East Midlands Nottingham 2 Research Ethics Committee of the Health Research Authority number 17/EM/0077 gave ethical approval for this work on 10/05/2017.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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The baseline data form part of the main trial database and will be used for covariate adjustment. The individual patient baseline data are not available although the whole trial database will become available eventually.