Joanna Wardlaw
Protocol: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease
Wardlaw, Joanna; Bath, Philip M.W.; Doubal, Fergus; Heye, Anna; Sprigg, Nikola; Woodhouse, Lisa J.; Blair, Gordon; Appleton, Jason; Cvoro, Vera; England, Timothy; Hassan, Ahamad; John Werring, David; Montgomery, Alan; The LACI-2 Trial Investigators
Authors
PHILIP BATH philip.bath@nottingham.ac.uk
Stroke Association Professor of Stroke Medicine
Fergus Doubal
Anna Heye
NIKOLA SPRIGG nikola.sprigg@nottingham.ac.uk
Professor of Stroke Medicine
Dr LISA WOODHOUSE L.Woodhouse@nottingham.ac.uk
Research Fellow
Gordon Blair
Jason Appleton
Vera Cvoro
TIMOTHY ENGLAND Timothy.England@nottingham.ac.uk
Professor of Stroke Medicine
Ahamad Hassan
David John Werring
ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit
The LACI-2 Trial Investigators
Abstract
Background
Small vessel disease causes a quarter of ischaemic strokes (lacunar subtype), up to 45% of dementia either as vascular or mixed types, cognitive impairment and physical frailty. 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 and/or isosorbide mononitrate (ISMN) by demonstrating adequate participant recruitment and retention in follow-up, drug tolerability, safety and confirm outcome event rates required to power a phase 3 trial.
Methods and 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 and 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 and functional outcomes, Trails B and brain MRI. LACI-2 is registered ISRCTN 14911850, EudraCT 2016–002277-35.
Trial outcome: Primary outcome is feasibility of recruitment and compliance; secondary outcomes include safety (cerebral or systemic bleeding, falls, death), efficacy (recurrent cerebral and cardiac vascular events, cognition on TICS, Trails B) and tolerability.
Summary
LACI-2 will determine feasibility, tolerability and provide outcome rates to power a large phase 3 trial to prevent progression of cerebral small vessel disease.
Citation
Wardlaw, J., Bath, P. M., Doubal, F., Heye, A., Sprigg, N., Woodhouse, L. J., …The LACI-2 Trial Investigators. (2020). Protocol: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease. European Stroke Journal, 5(3), 297-308. https://doi.org/10.1177/2396987320920110
Journal Article Type | Article |
---|---|
Acceptance Date | Mar 5, 2020 |
Online Publication Date | Apr 20, 2020 |
Publication Date | Sep 1, 2020 |
Deposit Date | May 4, 2020 |
Publicly Available Date | May 4, 2020 |
Journal | European Stroke Journal |
Electronic ISSN | 2396-9873 |
Publisher | SAGE Publications |
Peer Reviewed | Peer Reviewed |
Volume | 5 |
Issue | 3 |
Pages | 297-308 |
DOI | https://doi.org/10.1177/2396987320920110 |
Public URL | https://nottingham-repository.worktribe.com/output/4379869 |
Publisher URL | https://journals.sagepub.com/doi/full/10.1177/2396987320920110 |
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