Stroke Circulatory System Intracerebral haemorrhage
Conditions
Interventions
Subjects with symptomatic carotid stenosis causing stroke or TIA are split equally into two groups: the sodium valproate group and the control group (no treatment). Study participants randomly allocat
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
50 Years to 99 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 15/06/2021: 1. Have given written informed consent to participate 2. Be aged 50 years and over 3. Have had a recent (less than 6 months) symptomatic carotid atherosclerotic stroke or transient ischaemic attack (TIA) with carotid stenosis of 30-99%. This will be determined from clinical imaging such as US Duplex/ultrasound, CT Angiogram or MR Angiogram. The percentage of stenosis will be measured using NASCET criteria* *Patients with tight carotid stenosis (> 70%) will usually be offered carotid endarterectomy and therefore would not be suitable for the study. However many patients present with moderate carotid stenosis (30–70%) and do not receive carotid endarterectomy. Therefore we would anticipate that the majority of our patients will have this degree of stenosis (30-70%). In a recent observational study of PET in acute symptomatic carotid stenosis (ICARUSS, co-ordinated by Dr Nick Evans) approximately two thirds of all patients with carotid stenosis did not progress to endarterectomy and therefore we feel it is feasible to recruit this number of patients. Previous participant inclusion criteria: 1. Have given written informed consent to participate 2. Be aged 50 years and over 3. Have had a recent (less than one month) symptomatic carotid atherosclerotic stroke or transient ischaemic attack (TIA) with carotid stenosis of 30-99%. This will be determined from clinical imaging such as US Duplex/ultrasound, CT Angiogram or MR Angiogram. The percentage of stenosis will be measured using NASCET criteria* *Patients with tight carotid stenosis (> 70%) will usually be offered carotid endarterectomy and therefore would not be suitable for the study. However many patients present with moderate carotid stenosis (30–70%) and do not receive carotid endarterectomy. Therefore we would anticipate that the majority of our patients will have this degree of stenosis (30-70%). In a recent observational study of PET in acute symptomatic carotid stenosis (ICARUSS, co-ordinated by Dr Nick Evans) approximately two thirds of all patients with carotid stenosis did not progress to endarterectomy and therefore we feel it is feasible to recruit this number of patients.
Exclusion criteria
Exclusion criteria: 1. Unable/unwilling to consent 2. Contraindications to taking part in MRI study as assessed by the local MRI safety questionnaire, e.g., pacemaker 3. Women of childbearing potential* 4. Contraindications to sodium valproate including hepatic dysfunction 5. Atrial fibrillation 6. Known chronic kidney disease that would preclude contrast use: i.e Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 7. Planned endarterectomy 8. Taking medication contra-indicated to sodium valproate 9. Known hypersensitivity to sodium valproate or its excipients 10 Another diagnosed chronic neurological condition (e.g. Alzheimer's, Parkinson's disease, motor neurone disease, multiple sclerosis). 11. Limited life expectancy due to another illness or chronic condition making the 2 year treatment difficult (e.g. widespread malignancy). *A woman is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Women in childbearing potential who underwent permanent sterilisation which include hysterectomy, bilateral salpingectomy and bilateral oophorectomy will be eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline, 3 months and 2 years: 1. Carotid plaque volume will be assessed using CTA 2. Carotid plaque inflammation will be assessed by 18Fluoride-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG-PET/CT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, 3 months and 2 years: 1. Carotid plaque morphology will be assessed using CTA 2. Cognitive assessment score (MoCA) | — |
Countries
England, United Kingdom
Contacts
Public ContactLaurence Loubiere
Outcome results
None listed