SECONDARY PREVENTION OF SMALL SUBCORTICAL STROKES (SPS3)

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。SPS3研究由两个随机、多中心的临床试验组成。这项研究的目的是确定有效的治疗方法来预防有症状的皮质下小卒中患者的卒中复发和认知能力下降。第一项研究是第三阶段随机2X2对照试验。在3个月内出现S3症状的患者将被随机分为阿司匹林和氯吡格雷两组。疗效将通过平均3年的随访期间中风复发来确定。将在SPS3高血压试验中测试的指导性假设是，与“通常”管理(目标收缩压130-149毫米汞柱)相比，“密集”控制血压(目标收缩压低于130毫米汞柱)将导致较少的中风复发，较少的认知功能衰退，以及对生活质量没有不利影响的其他主要血管事件的减少。目的是比较两种水平的血压控制效果，而不是比较特定降压药的使用。在SPS3中，高血压的管理将基于国家指南中的“最佳实践”建议，以实现指定的目标。试验的血压成分将是开放标签的，使用在多中心高血压试验中广泛使用的所谓探针(前瞻性随机、开放标签与盲目事件评估)设计。注册时间为三年以上，另外还有一年半的后续工作(平均三年的后续工作)。一系列认知测试将在入学时、之后每年和研究结束时进行。在入选时和随后的短暂性脑缺血发作/中风/主要认知功能下降时，需要进行脑部核磁共振检查以证明合格。在血压达到目标水平后，将进行动态血压监测。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The SPS3 study consists of two randomized, multi-center clinical trials. The objectives of this study are to define efficacious therapies for prevention of stroke recurrence and cognitive decline in patients with symptomatic small subcortical stroke. The first study is a Phase III randomized 2X2 controlled trial. Patients with a symptomatic S3 within prior 3 months will be randomized to aspirin vs. aspirin + clopidogrel. Efficacy will be determined by recurrent stroke during a mean follow-up of 3 years. The guiding hypotheses to be tested in the SPS3 hypertension trial are that "intensive" control of blood pressure (target systolic BP of less than 130 mmHg) will result in fewer recurrent strokes, less cognitive decline, and a decrease in other major vascular events with no adverse impact on quality of life compared to "usual" management (target systolic BP of 130-149 mm Hg). The goal is to compare the effects of two levels of BP control, and not to compare the use of specific antihypertensive agents. Management of hypertension in SPS3 to achieve the assigned targets will be based on "best practice" recommendations from national guidelines. The blood pressure component of the trial will be open-label, using the so-called PROBE (Prospective Randomized, Open-label with Blinded Event assessment) design widely used in multicenter hypertension trials. Enrollment will be over three years, with an additional 1.5 years of follow up (mean follow up of three years). A battery of cognitive tests will be performed at entry, yearly thereafter, and at study end. Brain MRIs are required at entry to document eligibility and at the time of subsequent TIA/stroke/major cognitive decline. Ambulatory blood pressure monitoring will be performed after target levels of blood pressures are achieved.