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NCT04099238 Clinical Trial

Burden of Ischemic Stroke and Intake of Oral Anticoagulants in Patients With Atrial Fibrillation in the UK Primary Care

Atrial Fibrillation Clinical Trial

— BEST-AF  

Official title:
Burden of Ischemic Stroke and Adherence to Oral Anticoagulants in Atrial Fibrillation in the UK Primary Care

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04099238
Other study ID # 21094
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date July 16, 2020

Study information
Verified date April 2021
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 3739
Est. completion date July 16, 2020
Est. primary completion date July 16, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 89 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oral anticoagulant
Oral anticoagulants may comprise vitamin K antagonists (VKA) and non-vitamin K antagonist oral antagonists (NOAC).

Locations
Country Name City State
United Kingdom Many facilities Multiple Locations

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of subjects with ischemic stroke Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018
Primary Incidence of ischemic stroke Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018
Primary Number of NVAF patients with OAC prescription prior to ischemic stroke For NVAF subgroup only Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
Primary Duration of OAC treatment before OAC discontinuation for NVAF patients For NVAF subgroup only Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
Primary Time period from OAC discontinuation to ischemic stroke for NVAF patients For NVAF subgroup only Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
Primary Relative risk of NVAF patients for ischemic stroke after OAC discontinuation For NVAF subgroup only Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
Primary Relative risk of NVAF patients for ischemic stroke by time since OAC discontinuation For NVAF subgroup only Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
Primary Relative risk of NVAF patients for ischemic stroke by OAC treatment duration before OAC discontinuation For NVAF subgroup only Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
Primary Relative risk of NVAF patients for ischemic stroke after VKA discontinuation For NVAF subgroup only Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
Primary Relative risk of NVAF patients for ischemic stroke by time since VKA discontinuation For NVAF subgroup only Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
Primary Relative risk of NVAF patients for ischemic stroke by VKA treatment duration before VKA discontinuation For NVAF subgroup only Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
Primary Relative risk of NVAF patients for ischemic stroke after NOAC discontinuation For NVAF subgroup only Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
Primary Relative risk of NVAF patients for ischemic stroke by time since NOAC discontinuation For NVAF subgroup only Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
Primary Relative risk of NVAF patients for ischemic stroke by NOAC treatment duration before NOAC discontinuation For NVAF subgroup only Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
Secondary 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
Secondary 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
Secondary 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
Secondary Prevalence of cardiovascular co-morbidities one year before ischemic stroke Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
Secondary Prevalence of cardiovascular co-morbidities 12 months after ischemic stroke Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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