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

Overview

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.

Full Title of Study: “Burden of Ischemic Stroke and Adherence to Oral Anticoagulants in Atrial Fibrillation in the UK Primary Care”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: July 16, 2020

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

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

Arms, Groups and Cohorts

  • 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
  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • Number of subjects with ischemic stroke
    • Time Frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018
  • Incidence of ischemic stroke
    • Time Frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 Measures

  • 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
  • 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
  • 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
  • Prevalence of cardiovascular co-morbidities one year before ischemic stroke
    • Time Frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
  • Prevalence of cardiovascular co-morbidities 12 months after ischemic stroke
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 89 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor

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