Burden of Ischemic Stroke and Intake of Oral Anticoagulants in Patients With Atrial Fibrillation in the UK Primary Care (BEST-AF)

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Oral anticoagulant

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.

• Study Type: Observational
• Enrollment (Actual): 3739

Contacts and Locations

Study Locations

• United Kingdom
  • Multiple Locations, United Kingdom
    • Many facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults from UK with electronic medical records in The Health Improvement Network (THIN) database

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with ischemic stroke; Adult subjects from the UK THIN database who were hospitalized for ischemic stroke between 01-Jul-2016 to 30-Jun-2018	Drug: Oral anticoagulant; Oral anticoagulants may comprise vitamin K antagonists (VKA) and non-vitamin K antagonist oral antagonists (NOAC).; Other Names: Warfarin, acenocoumarol, phenindione, apixaban, dabigatran, edoxaban, rivaroxaban
NVAF patients with ischemic stroke; Adult subjects from the UK THIN database who were hospitalized for ischemic stroke between 01-Jul-2016 to 30-Jun-2018 and had a diagnosis of NVAF prior to ischemic stroke (Subgroup)	Drug: Oral anticoagulant; Oral anticoagulants may comprise vitamin K antagonists (VKA) and non-vitamin K antagonist oral antagonists (NOAC).; Other Names: Warfarin, acenocoumarol, phenindione, apixaban, dabigatran, edoxaban, rivaroxaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	For NVAF subgroup only	Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2019
• Primary Completion (ACTUAL): July 16, 2020
• Study Completion (ACTUAL): July 16, 2020

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (ACTUAL): September 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Ischemic stroke; Discontinuation; Non-valvular atrial fibrillation (NVAF); Oral anticoagulants (OAC); Vitamin K antagonists (NKA); Non-vitamin K antagonist oral anticoagulants (NOAC)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Ischemic Stroke; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Rivaroxaban; Dabigatran; Apixaban; Edoxaban; Warfarin; Anticoagulants; Acenocoumarol; Phenindione
• Other Study ID Numbers: 21094 (Other Identifier: City of Hope Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No