Patients & Carers

Aims of the research 

Our aim is to find new treatments for patients who have had a lacunar stroke. A lacunar stroke is different to other kinds of stroke and caused by disease in small blood vessels of the brain limiting blood flow. This small vessel disease can lead to dementia and further stroke. This new trial called LACI-3 will assess two drugs, isosorbide mononitrate (ISMN) and cilostazol, in patients who have had a lacunar stroke. We are UK experts who have worked together for over 10 years. 

Background 

Lacunar stroke is common - 35,000 people have a lacunar stroke in the UK per year, and it has serious consequences. Despite this there is no specific treatment for this type of stroke. 

We need this research now to find drugs that can help patients with lacunar stroke and fill this gap in clinical care. We selected these two drugs, ISMN and cilostazol, as they are already widely used in other diseases and could work in patients with lacunar stroke. 

LACI-3 builds on recent research in patients with a lacunar stroke. LACI-1 (57 patients) showed that they could tolerate these drugs. LACI-2 (363 patients) showed that these drugs may reduce the decline in memory and thinking and recurrence of strokes. We now need to confirm these findings in the larger LACI-3 trial. 

Design and methods 

We will perform a randomised trial to give the highest quality evidence to change guidelines. After their stroke, consented participants will come to the hospital/clinic, we will collect details and we will randomly allocate patients into groups and give out the trial medications. Each group will take one of two medications, or both together, or no medication at all (a comparison group) and everyone will get the best current medical therapy. 

We will telephone participants at 1 and 3 weeks, provide a helpline number and liaise with participants’ GPs, supplying drugs for 2 years. At 1 year and 2 years we will contact the participant by phone and post (or web based) to test memory and thinking and ask about medical conditions including new strokes, quality of life and any possible side effects. 

Based on the LACI-2 results, we calculate that LACI-3 will need 1300 participants from 60 UK centres to confirm if these drugs are beneficial. We are encouraged by having many notes of interest from hospitals who are keen to offer this trial. 

Patient and Public Involvement 

We have sought guidance on this proposal from patients who were in LACI-2, patients in the Edinburgh small vessel disease patient reference group, advisers from the previous LACI-1 trial and from the lay advisory group for one of our linked studies. 

We have 2 lay co-applicants. We will also form a LACI-3 lay reference group (balanced by geography, ethnicity and gender). All will comment on trial design, information leaflets, questionnaires, and methods of communicating with participants including plain English summaries. 

Dissemination 

We will communicate the trial results widely via newsletters to the trial participants and to the scientific/medical community via journal publications and international conferences (where LACI-2 generated much interest). We will also show results through our established networks and social media channels. 

As these drugs are already widely available (and inexpensive) they could be quickly adopted into stroke guidelines to reduce the global burden of disease from stroke and dementia. We will work with the NHS England Medicines Repurposing Programme to roll out their use.