SOLVE: Sodium valproate to prevent stroke

Not Applicable

• Conditions: Stroke; Circulatory System; Intracerebral haemorrhage

• Registration Number: ISRCTN12685153
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-02
• Last Update Posted: 29 January 2024
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 24

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Measured at baseline, 3 months and 2 years:<br> 1. Carotid plaque volume will be assessed using CTA<br> 2. Carotid plaque inflammation will be assessed by 18Fluoride-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG-PET/CT)<br>

Secondary Outcome Measures

Name	Time	Method
<br> Measured at baseline, 3 months and 2 years:<br> 1. Carotid plaque morphology will be assessed using CTA<br> 2. Cognitive assessment score (MoCA)<br>