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Completed

NCT Number: NCT04099238

Burden of Ischemic Stroke and Intake of Oral Anticoagulants in Patients With 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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

20 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Many facilities

Multiple Locations, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral anticoagulant

Drug

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

Primary outcomes

  1. Number of subjects with ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018

  2. Incidence of ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018

  3. Number of NVAF patients with OAC prescription prior to ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

    For NVAF subgroup only

  4. Duration of OAC treatment before OAC discontinuation for NVAF patients

    Time frame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

    For NVAF subgroup only

  5. Time period from OAC discontinuation to ischemic stroke for NVAF patients

    Time frame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

    For NVAF subgroup only

  6. Relative risk of NVAF patients for ischemic stroke after OAC discontinuation

    Time frame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

    For NVAF subgroup only

  7. Relative risk of NVAF patients for ischemic stroke by time since OAC discontinuation

    Time frame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

    For NVAF subgroup only

  8. Relative risk of NVAF patients for ischemic stroke by OAC treatment duration before OAC discontinuation

    Time frame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

    For NVAF subgroup only

  9. Relative risk of NVAF patients for ischemic stroke after VKA discontinuation

    Time frame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

    For NVAF subgroup only

  10. Relative risk of NVAF patients for ischemic stroke by time since VKA discontinuation

    Time frame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

    For NVAF subgroup only

  11. Relative risk of NVAF patients for ischemic stroke by VKA treatment duration before VKA discontinuation

    Time frame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

    For NVAF subgroup only

  12. Relative risk of NVAF patients for ischemic stroke after NOAC discontinuation

    Time frame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

    For NVAF subgroup only

  13. Relative risk of NVAF patients for ischemic stroke by time since NOAC discontinuation

    Time frame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

    For NVAF subgroup only

  14. Relative risk of NVAF patients for ischemic stroke by NOAC treatment duration before NOAC discontinuation

    Time frame: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

    For NVAF subgroup only

Secondary outcomes

  1. Number of subjects with first diagnosis of NVAF at time of ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018

  2. Number of subjects with first diagnosis of NVAF within 1 month after ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jul-2018

  3. Number of subjects with first diagnosis of NVAF within 12 months after ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

  4. Prevalence of cardiovascular co-morbidities one year before ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

  5. Prevalence of cardiovascular co-morbidities 12 months after ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

  6. Descriptive analysis of pharmacological treatments of patients with known NVAF diagnosis within 12 months before ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

  7. Descriptive analysis of pharmacological treatments of patients with known NVAF diagnosis within 12 months after ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

  8. Descriptive analysis of pharmacological treatments of patients without known NVAF diagnosis within 12 months before ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

  9. Descriptive analysis of pharmacological treatments of patients without known NVAF diagnosis within 12 months after ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

  10. Case-fatality of patients with known NVAF diagnosis at 1 month after ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

  11. Case-fatality for patients with known NVAF diagnosis at 12 months after ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

  12. Case-fatality of patients with unknown NVAF diagnosis at 1 month after ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

  13. Case-fatality of patients with unknown NVAF diagnosis at 12 months after ischemic stroke

    Time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: BEST-AF

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2019
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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