SOdium vaLproate to preVEnt stroke - SOLVE study - version 1.0
Research type
Research Study
Full title
Inhibiting HDAC9 as a novel treatment for large artery atherosclerotic stroke: a pilot study.
IRAS ID
289372
Contact name
Hugh S. Markus
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust And University of Cambridge
ISRCTN Number
ISRCTN12685153
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
In a very large study involving stroke patients from throughout the world, we have identified a new gene (called HDAC9) which increases the risk that someone will have stroke caused by narrowing of the blood vessels supplying the brain. This type of stroke is called large artery stroke and accounts for a quarter of all strokes. If the HDAC9 gene becomes ‘overactive’ it increases stroke risk. This raises the exciting possibility that if we could inhibit HDAC9 we could reduce stroke risk. A commonly used antiepileptic drug called sodium valproate inhibits the activity of HDAC9. Analysis of stroke registers involving thousands of patients has suggested that patients who take sodium valproate may have a lower risk of recurrent strokes. This suggests sodium valproate might prevent large artery stroke.
We now plan to test whether sodium valproate does indeed reduce stroke risk in a clinical study. We will recruit patients who have suffered a stroke or transient ischaemic attack (TIA) due to narrowing of the arteries to the brain. They will be randomised (allocated) between either sodium valproate or no treatment (control group). We will perform imaging of the blood vessels to the brain using CT angiography, PET/CT, and carotid MRI at the beginning of the study, after three months and after two years. We will then see whether patients on sodium valproate have reduced progression of narrowing of the arteries to the brain compared with patients taking no drug. If this study confirms that sodium valproate reduces narrowing of the arteries to the brain it may then offer an exciting treatment to prevent stroke. An advantage is that as a widely used drug that has been around for decades, sodium valproate has well understood side effects, and is not under patent so is cheap.REC name
London - City & East Research Ethics Committee
REC reference
21/LO/0037
Date of REC Opinion
1 Mar 2021
REC opinion
Further Information Favourable Opinion