SECONDARY PREVENTION OF SMALL SUBCORTICAL STROKES (SPS3)

小皮质下中风的二级预防 (SPS3)

• 批准号: 8069957
• 负责人: OSCAR R BENAVENTE
• 金额: $ 33.96万
• 依托单位: UNIVERSITY OF BRITISH COLUMBIA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-05 至 2012-03-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8069957
• 关键词: Active Sites; Address; American; Arteries; Aspirin; Blinded; Blood Platelets; Blood Pressure; Blood Vessels; Cerebrum; Clinical Trials; Cognitive; Dementia; Disease; Double-Blind Method; Enrollment; Event; Hispanics; Hypertension; Hypotension; Impaired cognition; Infarction; International; Intervention; Lead; Magnetic Resonance Imaging; Minority; Multi-Institutional Clinical Trial; Not Hispanic or Latino; Participant; Patients; Population; Prevention therapy; Randomized; Randomized Clinical Trials; Recurrence; Research Design; Research Personnel; Risk Factors; Risk Reduction; Secondary Prevention; Site; Stroke; Stroke prevention; Survivors; Testing; Time; Vascular Dementia; base; blood pressure regulation; clinical research site; clopidogrel; design; follow-up; high risk; open label; programs; randomized trial; response

DESCRIPTION (provided by applicant): Nearly two million survivors of small subcortical strokes (S3, a.k.a. lacunar infarcts) in the U.S. are at high risk for recurrent stroke and for developing vascular dementia. S3s are one of the most common stroke subtypes in Hispanics. The aims of the Secondary Prevention of Small Subcortical Strokes (SPSS) trial are to define efficacious therapies for prevention of recurrent stroke and cognitive decline in patients with S3. SPSS consists of two randomized, multi-center clinical trials and will enroll 2500 participants (20% of whom will be Hispanic) with symptomatic, MRI-defined S3. Patients are assigned to two interventions in a factorial design: 1. Anti-platelet Intervention: aspirin 325 mg/d vs. aspirin 325 mg/d plus clopidogrel 75 mg/d. 2. Blood Pressure Intervention: 'Usual' hypertension management with systolic blood pressure targets of 130 to 149 mm Hg vs. 'Intensive' hypertension management with systolic blood pressure targets <130 mm Hg. The anti-platelet comparison is double-blinded, while the blood pressure intervention is open-label with blinded assessment of events. Follow-up is every three months for an average of 3 years. The primary aims are: 1. To determine whether combination anti-platelet therapy is more efficacious than aspirin alone for reducing stroke recurrence and cognitive decline. 2. To determine whether 'intensive' blood pressure lowering to a specific target range is superior to 'usual' hypertension management for reducing recurrent strokes and cognitive decline. The original application proposed to enroll 2 patients per month at 35 clinical sites. Randomization started in 2003 and was lower than anticipated. In order to address this problem, we have added additional domestic and international sites, bringing active sites to 63. Recruitment has stabilized at around 40 participants per month over the past year and as of February 1, 2007, 1341 participants were enrolled. At the current rate of enrollment, we anticipate completing recruitment by July 2009, with one additional year of follow-up continuing past that time. No previous randomized trials have focused specifically on secondary prevention after S3, on optimal target levels of blood pressure control after stroke and their relationship to cognitive decline, or on prevention of stroke and dementia specifically in Hispanics. The results of SPSS will likely lead to an important reduction in the burden of stroke and vascular dementia for millions of people with S3, and particularly for Hispanics. The purpose of this application is to request support for continuation and completion of the SPS3 trial given the initial recruitment shortfall. The study design and objectives remain unchanged from the original application.

描述（由申请人提供）：在美国，近 200 万小型皮质下中风（S3，又名腔隙性梗塞）幸存者面临复发性中风和发展为血管性痴呆的高风险。 S3 是西班牙裔人中最常见的中风亚型之一。小皮质下中风二级预防 (SPSS) 试验的目的是确定预防 S3 患者复发性中风和认知能力下降的有效疗法。 SPSS 由两项随机、多中心临床试验组成，将招募 2500 名患有 MRI 定义的有症状 S3 的参与者（其中 20% 是西班牙裔）。在析因设计中，患者被分配接受两种干预措施： 1. 抗血小板干预：阿司匹林 325 mg/d 对比阿司匹林 325 mg/d 加氯吡格雷 75 mg/d。 2.血压干预：收缩压目标为130至149毫米汞柱的“常规”高血压管理与收缩压目标<130毫米汞柱的“强化”高血压管理。抗血小板比较是双盲的，而血压干预是开放标签的，对事件进行盲法评估。每三个月随访一次，平均 3 年。主要目的是： 1. 确定联合抗血小板治疗是否比单独使用阿司匹林更能有效减少中风复发和认知能力下降。 2. 确定“强化”血压降低至特定目标范围在减少中风复发和认知能力下降方面是否优于“常规”高血压治疗。最初的申请计划每月在 35 个临床中心招募 2 名患者。随机化从 2003 年开始，低于预期。为了解决这个问题，我们增加了更多的国内和国际网站，使活跃网站达到了 63 个。去年的招募人数稳定在每月 40 名参与者左右，截至 2007 年 2 月 1 日，已注册了 1341 名参与者。按照目前的注册率，我们预计在 2009 年 7 月之前完成招募，并在此之后继续进行一年的后续行动。之前没有随机试验专门关注 S3 后的二级预防、中风后血压控制的最佳目标水平及其与认知能力下降的关系，或特别是西班牙裔中风和痴呆的预防。 SPSS 的结果可能会显着减轻数百万 S3 患者（尤其是西班牙裔）的中风和血管性痴呆负担。鉴于最初的招募不足，本申请的目的是请求支持继续和完成 SPS3 试验。研究设计和目标与最初的申请保持不变。