SECONDARY PREVENTION IN SMALL SUBCORTICAL STROKES (SPS3)

小皮质下中风的二级预防 (SPS3)

• 批准号: 6394103
• 负责人: OSCAR R BENAVENTE
• 金额: $ 48.74万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 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 2002-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6394103
• 关键词: Mexican Americans; aspirin; behavior test; behavioral /social science research tag; blood pressure; cardiovascular disorder prevention; chemoprevention; clinical research; clinical trial phase I; drug adverse effect; drug screening /evaluation; essential hypertension; human subject; human therapy evaluation; magnetic resonance imaging; medical outreach /case finding; multiinfarct dementia; patient monitoring device; platelet aggregation inhibitors; racial /ethnic difference; stroke

Small subcortical strokes (S3), also known as lacunar infarcts, comprise nearly 25 percent of brain infarcts, are harbingers of vascular dementia, and are particularly frequent in Mexican- Americans. Combination antiplatelet therapy using clopidogrel plus aspirin and intensive lowering of blood pressure could substantially reduce major vascular events and cognitive decline in S3 patients. However, a large randomized clinical trial is required to define the efficacy and safety of these interventions specifically in patients with S3 due to presumed small vessel disease. This proposal is for a pilot study to: 1. Determine the lowest tolerable, achievable target blood pressures among survivors of S3. 2. To assess whether the difference between the lowest tolerable blood pressures are sufficiently different from that achieved by standard targets to substantially impact the occurrence of subsequent stroke and cognitive decline. 3. To quantitatively assess white matter abnormalities in S3 patient by serial MRI, correlating these with patient features, cognitive status, blood pressure control and antiplatelet treatment. 4. To assess the relationship of Mexican-American ethnicity to blood pressure interventions, tolerance of antiplatelet therapy, extent and progression of white matter abnormalities, and cognitive status, as well as to modify and assess existing screening tests of cognitive status for those who primarily speak Spanish. Participants with S3 attributed to small vessel disease will be randomized to treatment with aspirin (650mg/d) or aspirin plus clopidogrel (75mg/d) (double-blind), while those with a history of hypertension will additionally be randomized to three different target levels of blood pressure lowering (not blinded). The tolerance and achieved blood pressures in each target level will be the primary outcome, with tolerance and side-effects of antiplatelet therapy also assessed. Quantitative MRI will be done at entry and after a mean of one year, correlated with cognitive status, interventions and ethnicity. No clinical trials have assessed secondary prevention in S3, the most common type of stroke in Mexican Americans and accounting for about 150,000 strokes yearly in the US. While this pilot study is a necessary first-step for a larger, definitive clinical trial, valuable and unique information about blood pressure control after stroke and about issues relevant to stroke prevention in Mexican-Americans will emerge.

皮质下小卒中（S3），也称为腔隙性脑梗死，占脑梗死的近25%，是血管性痴呆的先兆，在墨西哥裔美国人中尤其常见。 使用氯吡格雷加阿司匹林的联合抗血小板治疗和强化降压可显著减少S3患者的主要血管事件和认知功能下降。 然而，需要进行一项大型随机临床试验来确定这些干预措施的有效性和安全性，特别是在假定的小血管疾病导致的S3患者中。本提案是一项试点研究，目的是：1.确定S3幸存者的最低可耐受、可达到的目标血压。 2.评估最低可耐受血压之间的差异是否与标准目标所达到的差异有足够大的差异，以显著影响后续卒中和认知能力下降的发生。 3.通过系列MRI定量评估S3患者的白色异常，并将其与患者特征、认知状态、血压控制和抗血小板治疗相关联。 4.评估墨西哥裔美国人种族与血压干预、抗血小板治疗耐受性、白色物质异常的程度和进展以及认知状态的关系，以及修改和评估主要讲西班牙语的人群的认知状态的现有筛查测试。小血管疾病导致的S3受试者将随机接受阿司匹林（650 mg/d）或阿司匹林+氯吡格雷（75 mg/d）治疗（双盲），而有高血压病史的受试者将额外随机接受三种不同的降压目标水平（非盲）。每个目标水平的耐受性和达到的血压将是主要结局，还评估了抗血小板治疗的耐受性和副作用。 将在入组时和平均一年后进行定量MRI，与认知状态、干预措施和种族相关。没有临床试验评估S3的二级预防，S3是墨西哥裔美国人最常见的中风类型，在美国每年约有15万例中风。 虽然这项试点研究是一个更大的，明确的临床试验的必要的第一步，有价值的和独特的信息，中风后的血压控制和有关的问题，中风预防在墨西哥裔美国人将出现。

项目成果

Left Ventricular Geometry on Transthoracic Echocardiogram and Prognosis after Lacunar Stroke: The SPS3 Trial.

经胸超声心动图的左心室几何形状和腔隙性卒中后的预后：SPS3 试验。

• DOI: 10.1016/j.jstrokecerebrovasdis.2015.03.005
• 发表时间: 2015
• 期刊: Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
• 作者: Field,ThaliaS;Pearce,LeslyA;Asinger,RichardW;Smyth,NathanGChan;De,SabeK;Hart,RobertG;Benavente,OscarR;SPS3Investigators
• 通讯作者: SPS3Investigators

Small vessel strokes.

• DOI: 10.1007/s11886-005-0006-6
• 发表时间: 2005-01-01
• 期刊: Current cardiology reports
• 影响因子: 3.7
• 作者: Benavente, Oscar;White, Carole L;Roldan, Ana M
• 通讯作者: Roldan, Ana M

Clinical features and racial/ethnic differences among the 3020 participants in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial.

小皮质下中风二级预防 (SPS3) 试验的 3020 名参与者的临床特征和种族/民族差异。

• DOI: 10.1016/j.jstrokecerebrovasdis.2012.03.002
• 发表时间: 2013
• 期刊: Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
• 作者: White,CaroleL;Szychowski,JeffM;Roldan,Ana;Benavente,Marie-France;Pretell,EdwinJ;DelBrutto,OscarH;Kase,CarlosS;Arauz,Antonio;Meyer,BrettC;Meissner,Irene;Demaerschalk,BartM;McClure,LeslieA;Coffey,ChristopherS;Pearce,Lesl
• 通讯作者: Pearce,Lesl

Antithrombotic therapy in small subcortical strokes (lacunar infarcts).

小型皮质下中风（腔隙性梗塞）的抗血栓治疗。

• 发表时间: 2003
• 期刊: Advances in neurology.
• 作者: Benavente,Oscar

Effects of long-term blood pressure lowering and dual antiplatelet treatment on cognitive function in patients with recent lacunar stroke: a secondary analysis from the SPS3 randomised trial.

• DOI: 10.1016/s1474-4422(14)70224-8
• 发表时间: 2014-12
• 期刊: The Lancet. Neurology
• 作者: Pearce LA;McClure LA;Anderson DC;Jacova C;Sharma M;Hart RG;Benavente OR;SPS3 Investigators
• 通讯作者: SPS3 Investigators