The effect of antiseizure medications on the effectiveness and safety of anticoagulants in patients with stroke: A population-based study in the United Kingdom.

Study type
Protocol
Date of Approval
Study reference ID
23_003293
Lay Summary

Seizure is an important complication following stroke, known as a common cardiovascular disease that occurs when there is an interruption in the blood flow to the brain. About 10% of people with this cardiovascular condition develop seizures and these people require ongoing treatment with antiseizure medications to control and prevent seizures. However, current clinical guidelines suggest avoiding the use of antiseizure medications with blood-thinning medications known as anticoagulants. Despite this, there is limited evidence on how these two medications interact and affect health outcomes in people with stroke. This study will be using de-identified GP and hospital admission records in the UK to better understand how antiseizure medications might affect the effectiveness and safety of using anticoagulants among people who have had a stroke. The findings of this study will support healthcare providers and policy makers to make better decisions when it comes to treating seizures in people with stroke.

Technical Summary

The aim of this study is to investigate the effect of antiseizure medication (ASM) on the effectiveness and safety of anticoagulants among people with stroke. A retrospective self-controlled case series study will be conducted using the UK Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) data. People who have been diagnosed with stroke between January 1, 2011 and December 31, 2020 will be identified using Read and SNOMED codes. Those who were prescribed with anticoagulant and ASM concurrently will be included. British National Formulary codes will be used to identify anticoagulant and ASM prescriptions. Outcomes of interest are recurrent stroke, major adverse cardiovascular events, and bleeding. ICD-10 diagnosis codes will be used to identify stroke-related outcomes from HES data. Conditional poison regression model will be used to estimate the incidence rate ratios by comparing incidence rates of recurrent stroke, MACE and bleeding between anticoagulant treatment period and combination treatment period in stroke patients. Subgroup analysis will be conducted by ASM regimen. Findings of this study could support healthcare providers and policy makers to make better decisions when treating seizure in stroke patients.

Health Outcomes to be Measured

Outcomes of interest are recurrent stroke, major adverse cardiovascular events (MACE) and bleeding after stroke.

Collaborators

Li Wei - Chief Investigator - University College London ( UCL )
Sohee Park - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Stella Kim - Collaborator - University College London ( UCL )
Wallis Lau - Collaborator - University College London ( UCL )

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation