Status: Ongoing First registered on: 27/06/2019
Last updated on: 02/03/2021
1. Study identification
EU PAS Register NumberEUPAS29923
Official titleUtilisation of oral anticoagulants in older people with atrial fibrillation in UK general practice
Study title acronym
Study typeObservational study
Brief description of the studyAtrial fibrillation (AF) is a heart condition that increases the risk of stroke. Blood thinning tablets known as oral anticoagulants (OACs) help to reduce the risk of stroke and guidelines recommend that OACs are prescribed to people with AF who also have other risk factors for stroke such as heart failure, high blood pressure or diabetes. Vitamin K antagonists (VKAs), such as warfarin, were the only OACs available. VKAs are difficult to manage as they require frequent blood tests and regular dose changes, they also interact with lots of other medicines and food. Historically, VKAs have been under-used in older people due to concerns about patients managing the complex dosing schedule if they have cognitive impairment, and also the risk of brain bleeds if they fall. Direct oral anticoagulants (DOACs) were introduced as an alternative to VKAs in 2008 but were not licensed for stroke prevention in AF until 2011. It is not known whether the introduction of DOACs has changed the rates of OAC prescribing for older people (aged 75 years and over) or how patient demographics, other medical conditions and concomitant prescribing affect the choice of OAC prescribed in UK general practice. The objectives of the study are: 1. To describe changes in the point prevalence and incidence of OAC prescribing by year prior to the introduction of DOACs (2003-2007), between the introduction of DOACs and the time they were recommended as an option by the National Institute for Health and Clinical Care Excellence (NICE) for stroke prevention in AF (2008-2012), and following publication of NICE technology appraisals recommending DOACs (2013-2017). 2. To describe switching between OACs during the study period. 3. To compare the characteristics of patients with AF who were newly started on OACs during each period described in objective 1, to those not prescribed an OAC in the same period. 4. To describe persistence with DOACs compared with warfarin.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUniversity of Bath
Department/Research groupPharmacy & Pharmacology
Organisation/affiliationUniversity of Bath
Website/Homepagewww.bath.ac.uk
Details of (Primary) lead investigator
Title Mrs
Last name Anneka
First name Mitchell
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/09/2018
Start date of data collection01/05/2019
Start date of data analysis30/07/201931/07/2019
Date of interim report, if expected
Date of final study report31/03/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
CharitiesThe Dunhill Medical Trust100
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mrs
Last name Anneka
First name Mitchell
Address line 1Dept. of Pharmacy & Pharmacology
Address line 2University of Bath 
Address line 3Claverton Down 
CityBath 
PostcodeBA2 7AY 
CountryUnited Kingdom
Phone number (incl. country code)44-1225-384215 
Alternative phone number 
Fax number (incl. country code) 
Email address a.mitchell@bath.ac.uk
Public Enquiries
Title Mrs 
Last name Anneka 
First name Mitchell 
Address line 1Dept. of Pharmacy & Pharmacology 
Address line 2University of Bath 
Address line 3Claverton Down 
CityBath 
PostcodeBA2 7AY 
CountryUnited Kingdom 
Phone number (incl. country code)44-1225-384215 
Alternative phone number 
Fax number (incl. country code) 
Email address a.mitchell@bath.ac.uk 
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