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Atrial FibrillationBEST-AFNCT04099238

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

An observational study of Atrial Fibrillation, run by Bayer at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 89 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Oral anticoagulant
Type of treatment
Pill or oral medicine
How many people
3,739 participants
Where
1 siteUnited Kingdom
Study dates
1 Oct 2019to 16 Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Many facilities

    Multiple Locations

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Oral anticoagulant
Keywords
Ischemic stroke, Non-valvular atrial fibrillation (NVAF), Oral anticoagulants (OAC), Vitamin K antagonists (NKA), Non-vitamin K antagonist oral anticoagulants (NOAC), Discontinuation
Medical subject headings
Atrial Fibrillation, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral anticoagulantDrug

    Also called Warfarin, acenocoumarol, phenindione, apixaban, dabigatran, edoxaban, rivaroxaban

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

Study groups in NCT04099238
Study groupRoleWhat they receive
Subjects with ischemic strokeAdult subjects from the UK THIN database who were hospitalized for ischemic stroke between 01-Jul-2016 to 30-Jun-2018
Receives: Drug: Oral anticoagulant
NVAF patients with ischemic strokeAdult 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)
Receives: Drug: Oral anticoagulant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with ischemic stroke

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

  2. Incidence of ischemic stroke

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

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

    For NVAF subgroup only

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

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

    For NVAF subgroup only

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

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

    For NVAF subgroup only

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

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

    For NVAF subgroup only

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

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

    For NVAF subgroup only

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

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

    For NVAF subgroup only

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

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

    For NVAF subgroup only

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

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

    For NVAF subgroup only

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

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

    For NVAF subgroup only

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

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

    For NVAF subgroup only

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

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

    For NVAF subgroup only

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

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

    For NVAF subgroup only

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

Secondary outcomes (13)

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

    Measured: 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

    Measured: 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

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

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

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

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2019
  2. Study start1 Oct 2019
  3. Primary completion16 Jul 2020
  4. Study completion16 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
3,739 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04099238
Sponsor's protocol ID
21094
Acronym
BEST-AF
Status last verified
Apr 2021
First submitted
20 Sep 2019
Last updated
26 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Bayer at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with ischemic stroke (time frame: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04099238.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.

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