A study of direct oral anticoagulants for patients with a first stroke
Research type
Research Study
Full title
A descriptive non-interventional study to evaluate the use of direct oral anticoagulants in UK clinical practice for patients with a first stroke attributable to nonvalvular atrial fibrillation
IRAS ID
253458
Contact name
James Uprichard
Contact email
Sponsor organisation
Daiichi Sankyo UK
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
This is a United Kingdom (UK), multi-centre, mixed methodology, non-interventional study.
This study will be conducted in 5 National Health Service centres in the UK. The study is based on both retrospective secondary use of hospital and/or primary care data from medical records (primary care data requested from the patients’ General Practitioner [GP] or family doctor) and also prospective data collection from medical records (paper-based and/or electronic, as appropriate). The study will also involve prospectively collected patient-reported data using questionnaires.
The population for this study is adult patients who have had a first ischaemic stroke (an ‘ischaemic stroke’ is a type of stroke that happens when a blood vessel supplying the brain becomes blocked by a blood clot). The study will include patients who have had a first ischaemic stroke caused by a condition called ‘nonvalvular Atrial fibrillation (AF)’, which is a type of irregular heart rhythm. The study is expected to recruit 300 patients in total.
Data will be collected retrospectively from medical records of all patients in the study (Group 1) for the 12 month period before the date of diagnosis of a first ischaemic stroke. For a subgroup of these patients (Group 2) who receive a particular type of blood thinning medication known as a ‘direct oral anticoagulant’ (DOAC), prospective data will also be collected from medical records and patients will be asked to complete questionnaires at 3 and 6 months after the first DOAC dose (and at the time of the first dose of DOAC treatment, where applicable).
REC name
London - South East Research Ethics Committee
REC reference
18/LO/1923
Date of REC Opinion
3 Jan 2019
REC opinion
Further Information Favourable Opinion