Standard medical management in secondary prevention of ischemic stroke in China (SMART)
Standard medical management in secondary prevention of ischemic stroke in China (SMART)
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DOI：
10.1111/j.1747-4949.2011.00648.x
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发表时间：
2011-10-01
影响因子：
6.7
通讯作者：
Pu, Chuanqiang
中科院分区：
文献类型：
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作者：
Peng, Bin;Zhu, Yicheng;Pu, Chuanqiang
背景 虽然继发性缺血性脑卒中的指南已经制定，但指南与临床实践之间存在差距。 目的 本研究将调查我国缺血性脑卒中二级预防的现状，在缺血性脑卒中和/或短暂性脑缺血发作患者中实施标准医疗方案，并检验该方案的可行性和有效性。 设计 这是一项多中心、平行、随机、开放标签的对照试验，旨在评估基于推荐指南的方案（SMART）在脑卒中二级预防中的可行性和有效性。中国大陆48个站点将参与试验。该研究的入组患者人数为 4074 名。主要结局包括遵守 SMART 计划推荐的合格措施的患者比例（该措施源自当前的缺血性中风预防指南）以及实现治疗目标的患者比例。次要结局包括新发缺血性中风、出血性中风、急性冠状动脉综合征和所有原因死亡。该研究已在临床试验上注册。政府（NCT00664846）；迄今为止，已有 3380 名患者入组。
Background Although guidelines for secondary ischemic stroke have been developed, there is a gap between guidelines and clinic practice.Aims This study will investigate the current status of secondary ischemic stroke prevention in China, and implement a standard medical program in ischemic stroke and/or transient ischemic attack patients, and to examine the feasibility and efficacy of the program.Design This is a multicentre, parallel, randomized, open label, controlled trial to evaluate the feasibility and efficacy of a recommended guideline based program (SMART) in secondary stroke prevention. Forty-eight sites across Mainland China will participate in the trial. The number of enrolled patients in the study will be 4074. Primary outcome includes the proportion of patients adherent to eligible measures recommend by the SMART program, which is derived from current prevention guidelines for ischemic stroke, and the proportion of the patients achieving the treatment target. Secondary outcomes include new onset ischemic stroke, hemorrhagic stroke, acute coronary syndrome and all causes of death. The study has been registered on Clinicaltrials. gov (NCT00664846); to date, 3380 patients have been enrolled.