General Practice and Primary Care Research Unit, Institute of Public Health, University of Cambridge, Forvie Site, Robinson Way, Cambridge CB2 0SR, UK.
Trials. 2013 Jul 2;14:194. doi: 10.1186/1745-6215-14-194.
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.
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.
ISRCTN62019087.
短暂性脑缺血发作（TIA）或小中风的患者发生再次中风的风险较高，尤其是在事件发生后的第一周内。早期开始二级预防药物治疗可使中风复发风险降低 80%。这就提出了一个问题，即这些药物是否应该在专科医生就诊之前，也就是在初级保健或急诊科使用。RAPID-TIA 试验的目的是确定随机对照试验的可行性，分析成本效益，并提出以下问题：在将疑似 TIA 或小中风的患者转介给专科医生时，全科医生和急诊医生（初级保健医生）是否应该除了使用阿司匹林外，还应开始使用二级预防措施？
方法/设计：这是一项试点随机对照试验，其中包括初级保健医生对 TIA 诊断准确性的子研究。在试点试验中，我们计划从 30 家全科诊所（包括非工作时间的全科医疗中心）和 1 家急诊科招募 100 名患者，这些患者由初级保健医生诊断为 TIA 或小中风，并随机分配至常规治疗组（即开始使用阿司匹林并转介至 TIA 诊所）或常规治疗加早期二级预防药物治疗组（降压方案、辛伐他汀 40mg 和双嘧达莫 200mg m/r bd）。主要研究的主要结局是 90 天内的中风数量。诊断准确性子研究将包括这 100 名患者和另外 70 名初级保健医生认为可能诊断为 TIA 而非可能诊断为 TIA 的患者。对于试点试验，我们将报告招募率、随访率、主要事件发生率的初步估计以及任何不良事件的发生情况。对于诊断研究，我们将使用最终的 TIA 诊所诊断作为参考标准，计算初级保健医生诊断的灵敏度和特异性。
这项试点研究将用于估计设计主要研究所需的关键参数，并估计初级保健医生对 TIA 的诊断准确性。计划进行的后续试验将对疑似 TIA 患者的初始治疗产生重要影响。
ISRCTN62019087。
