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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099238
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.


Condition or disease Intervention/treatment
Atrial Fibrillation 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.

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Study Type : Observational
Actual Enrollment : 3739 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Burden of Ischemic Stroke and Adherence to Oral Anticoagulants in Atrial Fibrillation in the UK Primary Care
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : July 16, 2020
Actual Study Completion Date : July 16, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Warfarin, acenocoumarol, phenindione, apixaban, dabigatran, edoxaban, rivaroxaban




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults from UK with electronic medical records in The Health Improvement Network (THIN) database
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099238


Locations
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United Kingdom
Many facilities
Multiple Locations, United Kingdom
Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04099238    
Other Study ID Numbers: 21094
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Ischemic stroke
Non-valvular atrial fibrillation (NVAF)
Oral anticoagulants (OAC)
Vitamin K antagonists (NKA)
Non-vitamin K antagonist oral anticoagulants (NOAC)
Discontinuation
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Warfarin
Rivaroxaban
Dabigatran
Apixaban
Edoxaban
Acenocoumarol
Phenindione
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action