Stroke Studies

The following studies are being carried out at the Somerset Foundation Trust.

PLORAS

Predicting Language Outcome and Recovery After Stroke (PLORAS)

PLORAS is a research project looking at recovery of speech and language difficulties after stroke. The aim is to give future stroke survivors a prediction about their speech and language recovery.

If you, or someone you know is experiencing speech and language difficulties after a stroke and would like to be part of this project, please contact Research@SomersetFT.nhs.uk.

The first contact will be with a member of the research team from Somerset Foundation Trust, however more information is available on the main PLORAS website

Recruitment End Date:  20/08/2027

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.

A quarter of strokes, called lacunar strokes, are caused by disease of the smallest blood vessels in the brain. This ‘small vessel disease’ can also cause problems with thinking, balance and walking and can sometimes lead to dementia.

Whilst there are some treatments that help prevent some types of stroke from happening again, we think these may not work very well in lacunar stroke. There are no treatments yet to help the small blood vessels work better. As a result, damage to the brain may continue to build up.

The aim of this research is to test two possible new treatments for lacunar stroke in a clinical trial called the ‘Lacunar Intervention Trial 2’ (LACI-2).            

We have found two drugs which we think may reduce damage to the small blood vessels in the brain and therefore could prevent strokes and thinking problems due to small vessel disease.

The two drugs are widely used to treat other diseases, but have not been used to treat small vessel disease before.

One drug, called Cilostazol, is most commonly used in the UK to treat problems with the blood supply to the legs, but is used to prevent more strokes from happening in many countries outside the UK.

The other drug, called Isosorbide Mononitrate, is commonly used all over the world including in the UK to treat angina (pains in the chest due to poor blood supply to the heart).

We want to test if these drugs can help prevent the small vessel disease from causing another stroke or affecting the thinking skills, if they can be used safely in patients with small vessel disease, and if they can be taken for at least a year.

After consent and baseline information is gathered, and eligibility for the Trial is confirmed, a computer will make a random choice as to which Trial drug(s) the participant will take. They may be given cilostazol only, isosorbide only, both isosorbide and cilostazol, or neither drug but continue on their usual medication. If there is any medical reason why the participant cannot take one of the Trial drugs, then they can still join the Trial with the other drug.

Following the randomisation, participants who are to take the Trial drugs will be given the Trial medication for the first six months (some hospitals may give for three months) to take home to begin taking the following day, with instructions about when to take the tablets and how many. The participant will start on a low dose of the tablets and over the first 2-4 weeks this will be increased until they reach the dose that they are comfortable with. They will continue all their normal medications when taking the Trial drug(s) unless told otherwise.

Participation in the Trial will involve up to 4 visits to the hospital and 5 or 6 telephone calls over a year. The first visit will take approximately 2 hours, but the visit/s every 3 or 6 months to collect the next batch of tablets will not take more than 30 minutes and the scan visit at 12 months will take about an hour. Each telephone call should last no longer than 15 minutes.

Website address: https://www.ed.ac.uk/usher/edinburgh-clinical-trials/our-studies/ukcrc-studies/laci

RETAKE – Return to Work After Stroke

RETurn to work After stroKE (RETAKE) Early vocational rehabilitation compared with usual care for stroke survivors: an individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations.

Patients identified through the Stroke Early Discharge Service.  Intervention provided by Stroke OT.  Follow ups completed at home.

Principle Investigator – Sarah Dunne, Stroke Co-ordinator

Closed to recruitment in follow-up

PRESTIGE-AF (stroke)

In this research study we are investigating the best prevention of ischaemic strokes for patients who have a common heart arrhythmia called atrial fibrillation (AF) and who recently had a bleed in their brain called an ‘intracerebral haemorrhage’. An ischaemic stroke is a stroke caused by a blood clot blocking a blood vessel that supplies part of the brain. Having AF makes you more likely to suffer from an ischaemic stroke as it can cause blood clots to form in the heart, which can travel up to the brain.

The standard ischaemic stroke prevention for patients with AF is to use an anticlotting drug called an “anticoagulant” to help prevent blood clots forming. However, a side effect of anticoagulants is that they can make patients more likely to bleed. It is not known whether patients who have had an intracerebral haemorrhage should take anticoagulants for ischaemic stroke prevention and that is what we are testing in this study.

Half of the participants in the trial will take an anticoagulant medication and half will not. We will be measuring how safe it is for these patients to take anticoagulant medication and how effective it is for preventing ischaemic strokes.

The study has three additional sub-studies in which participants of the main trial may choose to take part in as well.

  • The sub-study ‘Predictive Modelling of Risk’ will explore the usefulness of genetic factors, brain imaging and blood-based biomarkers to improve the prediction of ischaemic and bleeding events in individual patients.
  • The brain imaging sub-study will look at the changes in the brain occurring during a 12 months observation period after enrolment in a subset of participants.
  • The pharmacology sub-study will look at levels of anticoagulant medication in the blood and examine the participants´ ability and willingness to take anticoagulant medication.

Recruitment End Date: 31/12/2021

The PRESTIGE-AF Study has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 754517.