SECONDARY PREVENTION OF SMALL SUBCORTICAL STROKES (SPS3)

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。SPS3研究包括两项随机、多中心临床试验。本研究的目的是确定有效的治疗方法，以预防症状性小皮质下卒中患者的卒中复发和认知能力下降。第一项研究是一项III期随机2X2对照试验。前3个月内出现S3症状的患者将随机分为阿司匹林组和阿司匹林+氯吡格雷组。疗效将通过平均3年随访期间卒中复发来确定。SPS3高血压试验中需要验证的指导假设是，与“常规”控制（目标收缩压130-149毫米汞柱）相比，“强化”控制血压（目标收缩压低于130毫米汞柱）将导致更少的卒中复发、更少的认知能力下降和其他主要血管事件的减少，对生活质量没有不利影响。目的是比较两种血压控制水平的效果，而不是比较特定降压药的使用。根据国家指南的“最佳做法”建议，对SPS3中的高血压进行管理，以实现指定的目标。该试验的血压成分将是开放标签的，采用所谓的PROBE（前瞻性随机、开放标签、盲法事件评估）设计，广泛应用于多中心高血压试验。入组时间将超过三年，另外还有1.5年的随访（平均随访时间为三年）。在入组时、此后每年以及研究结束时将进行一系列认知测试。在入组时以及随后的TIA/中风/严重认知能力下降时，需要进行脑部核磁共振检查以证明其资格。血压达到目标水平后进行动态血压监测。

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.