Atrial Fibrillation
Conditions
Keywords
Ischemic stroke, Non-valvular atrial fibrillation (NVAF), Oral anticoagulants (OAC), Vitamin K antagonists (NKA), Non-vitamin K antagonist oral anticoagulants (NOAC), Discontinuation
Brief summary
This study will characterize patients with ischemic stroke, a condition which occurs when a vessel supplying blood to the brain is obstructed, and a subpopulation of patients with irregular and often rapid heart rate (atrial fibrillation) in a UK general population using The Health Improvement Network (THIN) database. The main aim of the study is to estimate in how many patients atrial fibrillation was diagnosed at the moment of stroke and to describe whether these patients received OAC at the time of the stroke. In addition, researchers want to learn about the relative risk of ischemic stroke when such patients did not continue OAC treatment.
Detailed description
The primary objectives of the study are to determine the incidence of ischemic stroke in patients registered in the British primary care THIN database and to investigate the OAC exposure, OAC treatment patterns and the relative risk of having an ischemic stroke in relation to OAC treatment for a subgroup of patients, who were diagnosed with non-valvular atrial fibrillation (NVAF) prior to ischemic stroke. Secondary objectives are to determine the number of patients having NVAF diagnosed at the time of ischemic stroke and within 1 and 12 months after ischemic stroke; to describe cardiovascular risk factors for ischemic stroke and pharmacological treatments before and 12 months after ischemic stroke, and to estimate the case-fatality at 1 and 12 months after the occurrence of ischemic stroke.
Interventions
Oral anticoagulants may comprise vitamin K antagonists (VKA) and non-vitamin K antagonist oral antagonists (NOAC).
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Occurrence of an ischemic stroke that lead to hospitalization between 01-Jul-2016 to 30-Jun-2018 and concerned adults registered in the THIN database * Subgroup: Patients with diagnosed NVAF prior or at the time of ischemic stroke
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative risk of NVAF patients for ischemic stroke by NOAC treatment duration before NOAC discontinuation | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 | For NVAF subgroup only |
| Number of subjects with ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018 | — |
| Incidence of ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018 | — |
| Number of NVAF patients with OAC prescription prior to ischemic stroke | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 | For NVAF subgroup only |
| Duration of OAC treatment before OAC discontinuation for NVAF patients | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 | For NVAF subgroup only |
| Time period from OAC discontinuation to ischemic stroke for NVAF patients | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 | For NVAF subgroup only |
| Relative risk of NVAF patients for ischemic stroke after OAC discontinuation | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 | For NVAF subgroup only |
| Relative risk of NVAF patients for ischemic stroke by time since OAC discontinuation | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 | For NVAF subgroup only |
| Relative risk of NVAF patients for ischemic stroke by OAC treatment duration before OAC discontinuation | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 | For NVAF subgroup only |
| Relative risk of NVAF patients for ischemic stroke after VKA discontinuation | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 | For NVAF subgroup only |
| Relative risk of NVAF patients for ischemic stroke by time since VKA discontinuation | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 | For NVAF subgroup only |
| Relative risk of NVAF patients for ischemic stroke by VKA treatment duration before VKA discontinuation | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 | For NVAF subgroup only |
| Relative risk of NVAF patients for ischemic stroke after NOAC discontinuation | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 | For NVAF subgroup only |
| Relative risk of NVAF patients for ischemic stroke by time since NOAC discontinuation | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 | For NVAF subgroup only |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with first diagnosis of NVAF within 1 month after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jul-2018 |
| Number of subjects with first diagnosis of NVAF within 12 months after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Prevalence of cardiovascular co-morbidities one year before ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Prevalence of cardiovascular co-morbidities 12 months after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Descriptive analysis of pharmacological treatments of patients with known NVAF diagnosis within 12 months before ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Descriptive analysis of pharmacological treatments of patients with known NVAF diagnosis within 12 months after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Descriptive analysis of pharmacological treatments of patients without known NVAF diagnosis within 12 months before ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Descriptive analysis of pharmacological treatments of patients without known NVAF diagnosis within 12 months after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Case-fatality of patients with known NVAF diagnosis at 1 month after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Case-fatality for patients with known NVAF diagnosis at 12 months after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Case-fatality of patients with unknown NVAF diagnosis at 1 month after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Case-fatality of patients with unknown NVAF diagnosis at 12 months after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Number of subjects with first diagnosis of NVAF at time of ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018 |
Countries
United Kingdom
Outcome results
None listed