Open Access Study protocol

RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID−TIA): study protocol for a pilot randomised controlled trial

Duncan Edwards1, Kate Fletcher2, Rachel Deller2, Richard McManus3, Daniel Lasserson3, Matthew Giles4, Don Sims5, John Norrie6, Graham McGuire7, Simon Cohn1, Fiona Whittle1, Vikki Hobbs1, Christopher Weir6 and Jonathan Mant1*

Author Affiliations

1 General Practice and Primary Care Research Unit, Institute of Public Health, University of Cambridge, Forvie Site, Robinson Way, Cambridge CB2 0SR, UK

2 Department of Primary Care and General Practice, Clinical Sciences Building, The University of Birmingham, Edgbaston B15 2TT, UK

3 Department of Primary Health Care, University of Oxford, Rosemary Rue Building, Old Road Campus, Headington, Oxford OX3 7LF, UK

4 Stroke Prevention Research Unit, Department of Clinical Neurology, University of Oxford, Level 6, West Wing, John Radcliffe Hospital, Oxford OX3 9DU, UK

5 Department of Geriatric Medicine, University Hospital Birmingham NHS Trust, Birmingham B29 6JD, UK

6 Robertson Centre for Biostatistics, University of Glasgow, Glasgow G12 8QQ, UK

7 Stroke Research Network, NIHR Stroke Research Network Coordinating Centre, Bioscience Centre, International Centre for Life, Times Square, Newcastle upon Tyne NE1 4EP, UK

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Trials 2013, 14:194  doi:10.1186/1745-6215-14-194

Published: 2 July 2013

Abstract

Background

People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist – that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist?

Methods/Design

This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the reference standard.

Discussion

This pilot study will be used to estimate key parameters that are needed to design the main study and to estimate the accuracy of primary care diagnosis of TIA. The planned follow-on trial will have important implications for the initial management of people with suspected TIA.

Trial registration

ISRCTN62019087