Clinical trial NCT04099238: Burden of Ischemic Stroke and Intake of Oral Anticoagulants in Patients With Atrial Fibrillation in the UK Primary Care
Official title: Burden of Ischemic Stroke and Adherence to Oral Anticoagulants in Atrial Fibrillation in the UK Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Ischemic stroke
Non-valvular atrial fibrillation (NVAF)
Oral anticoagulants (OAC)
Vitamin K antagonists (NKA)
Non-vitamin K antagonist oral anticoagulants (NOAC)
Discontinuation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-09-23
Enrollment: 3739
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults from UK with electronic medical records in The Health Improvement Network (THIN) database

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018
measure: Incidence of ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018
measure: Number of NVAF patients with OAC prescription prior to ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
measure: Duration of OAC treatment before OAC discontinuation for NVAF patients
timeFrame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
measure: Time period from OAC discontinuation to ischemic stroke for NVAF patients
timeFrame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
measure: Relative risk of NVAF patients for ischemic stroke after OAC discontinuation
timeFrame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
measure: Relative risk of NVAF patients for ischemic stroke by time since OAC discontinuation
timeFrame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
measure: Relative risk of NVAF patients for ischemic stroke by OAC treatment duration before OAC discontinuation
timeFrame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
measure: Relative risk of NVAF patients for ischemic stroke after VKA discontinuation
timeFrame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
measure: Relative risk of NVAF patients for ischemic stroke by time since VKA discontinuation
timeFrame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
measure: Relative risk of NVAF patients for ischemic stroke by VKA treatment duration before VKA discontinuation
timeFrame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
measure: Relative risk of NVAF patients for ischemic stroke after NOAC discontinuation
timeFrame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
measure: Relative risk of NVAF patients for ischemic stroke by time since NOAC discontinuation
timeFrame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
measure: Relative risk of NVAF patients for ischemic stroke by NOAC treatment duration before NOAC discontinuation
timeFrame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
Secondary outcomes:
measure: Number of subjects with first diagnosis of NVAF at time of ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018
measure: Number of subjects with first diagnosis of NVAF within 1 month after ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jul-2018
measure: Number of subjects with first diagnosis of NVAF within 12 months after ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
measure: Prevalence of cardiovascular co-morbidities one year before ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
measure: Prevalence of cardiovascular co-morbidities 12 months after ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
measure: Descriptive analysis of pharmacological treatments of patients with known NVAF diagnosis within 12 months before ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
measure: Descriptive analysis of pharmacological treatments of patients with known NVAF diagnosis within 12 months after ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
measure: Descriptive analysis of pharmacological treatments of patients without known NVAF diagnosis within 12 months before ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
measure: Descriptive analysis of pharmacological treatments of patients without known NVAF diagnosis within 12 months after ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
measure: Case-fatality of patients with known NVAF diagnosis at 1 month after ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
measure: Case-fatality for patients with known NVAF diagnosis at 12 months after ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
measure: Case-fatality of patients with unknown NVAF diagnosis at 1 month after ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
measure: Case-fatality of patients with unknown NVAF diagnosis at 12 months after ischemic stroke
timeFrame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
Other outcomes:
Locations:
city: Multiple Locations
country: United Kingdom
facility: Many facilities
Study officials:
References: