Department of Neurology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.
BMC Neurol. 2013 Jan 24;13:11. doi: 10.1186/1471-2377-13-11.
Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. Support programs with multifactorial risk factor modifications after stroke or TIA have not been investigated in large-scale prospective controlled trials so far. INSPiRE-TMS is a prospective, multi-center, randomized open intervention trial for intensified secondary prevention after minor stroke and TIA.
METHODS/DESIGN: Patients with acute TIA or minor stroke admitted to the participating stroke centers are screened and recruited during in-hospital stay. Patients are randomised in a 1:1 ratio to intervention (support program) and control (usual care) arms. Inclusion of 2.082 patients is planned. The support program includes cardiovascular risk factor measurement and feedback, monitoring of medication adherence, coaching in lifestyle modifications, and active involvement of relatives. Standardized motivational interviewing is used to assess and enhance patients' motivation. Primary objective is a reduction of new major vascular events defined as nonfatal stroke and myocardial infarction or vascular death. Recruitment time is planned for 3.5 years, follow up time is at least 2 years for every patient resulting in a total study time of 5 years (first patient in to last patient out).
Given the high risk for vascular re-events in acute stroke and the available effective strategies in secondary prevention, the INSPIRE-TMS support program has the potential to lead to a relevant reduction of recurrent events and a prolongation of the event-free survival time. The trial will provide the basis for the decision whether an intensified secondary prevention program after stroke should be implemented into regular care. A cost-effectiveness evaluation will be performed.
clinicaltrials.gov: 01586702.
近期发生过中风或 TIA 的患者存在新发血管事件的高风险。有一些基于证据的中风二级预防策略，但常常未被充分应用。到目前为止，还没有在大规模前瞻性对照试验中研究过中风或 TIA 后的支持计划，其具有多因素危险因素修正。INSPiRE-TMS 是一项针对小中风和 TIA 后强化二级预防的前瞻性、多中心、随机开放干预试验。
方法/设计：参与卒中中心的急性 TIA 或小中风患者在住院期间接受筛选和招募。患者按 1:1 比例随机分为干预（支持计划）和对照组（常规护理）。计划纳入 2082 例患者。支持计划包括心血管危险因素测量和反馈、药物依从性监测、生活方式改变的指导以及亲属的积极参与。标准化动机访谈用于评估和增强患者的动机。主要目标是减少新发主要血管事件，定义为非致命性中风和心肌梗死或血管性死亡。招募时间计划为 3.5 年，每位患者的随访时间至少为 2 年，总研究时间为 5 年（首例患者入组至最后一例患者出组）。
鉴于急性中风患者再发血管事件的风险较高，以及二级预防中可用的有效策略，INSPiRE-TMS 支持计划有可能显著减少复发事件，并延长无事件生存时间。该试验将为是否应将强化二级预防方案纳入常规护理做出决策提供依据。将进行成本效益评估。
clinicaltrials.gov：01586702。
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