check_circleStudy Completed

Atrial fibrillation

Bayer Identifier:

21094

ClinicalTrials.gov Identifier:

NCT04099238

EudraCT Number:

Not Available

EU CT Number:

Not Available
Burden of ischemic stroke and intake of oral anticoagulants in patients with atrial fibrillation in the UK primary care

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

20 - 89 Years
  • - 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
  • - None

Trial summary

Enrollment Goal
3739
Trial Dates
October 2019 - July 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many facilitiesMany locations, United Kingdom

Primary Outcome

  • Number of subjects with ischemic stroke
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018
  • Incidence of ischemic stroke
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

Secondary Outcome

  • Number of subjects with first diagnosis of NVAF at time of ischemic stroke
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
  • Prevalence of cardiovascular co-morbidities one year before ischemic stroke
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019
  • Prevalence of cardiovascular co-morbidities 12 months after ischemic stroke
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

Trial design

Burden of ischemic stroke and adherence to oral anticoagulants in atrial fibrillation in the UK primary care
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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