SECONDARY PREVENTION OF SMALL SUBCORTICAL STROKES (SPS3)

小皮质下中风的二级预防 (SPS3)

• 批准号: 7378000
• 负责人: JOSEPH S HANNA
• 金额: $ 1.65万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378000
• 关键词: SECONDARY; PREVENTION; SMALL; SUBCORTICAL; STROKES

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。 SPS3研究由两项随机、多中心临床试验组成。本研究的目的是确定预防有症状的小皮质下中风患者中风复发和认知能力下降的有效疗法。 第一项研究是 III 期随机 2X2 对照试验。过去 3 个月内出现 S3 症状的患者将被随机分配到阿司匹林组与阿司匹林 + 氯吡格雷组。疗效将根据平均随访 3 年期间的复发性中风来确定。 SPS3高血压试验中要测试的指导假设是，与“常规”管理（目标收缩压为130-149 mmHg）相比，“强化”血压控制（目标收缩压低于130 mmHg）将减少中风复发、认知能力下降以及其他主要血管事件的减少，且不会对生活质量产生不利影响。 目的是比较两个血压控制水平的效果，而不是比较特定抗高血压药物的使用。 SPS3 中为实现指定目标而进行的高血压管理将基于国家指南的“最佳实践”建议。该试验的血压部分将是开放标签的，采用广泛用于多中心高血压试验的所谓PROBE（前瞻性随机、开放标签盲事件评估）设计。入组时间将超过三年，并有额外 1.5 年的随访（平均随访三年）。 一系列认知测试将在入学时、此后每年以及研究结束时进行。入职时以及随后发生 TIA/中风/严重认知能力下降时都需要进行脑部 MRI 扫描以记录资格。达到目标血压水平后将进行动态血压监测。