SECONDARY PREVENTION OF SMALL SUBCORTICAL STROKES (SPS3)

小皮质下中风的二级预防 (SPS3)

• 批准号: 7211467
• 负责人: OSCAR R BENAVENTE
• 金额: $ 772.72万
• 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 2008-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7211467
• 关键词: Accounting; Age; American; Arteries; Aspirin; Blinded; Blood Pressure; Blood Vessels; Cardiac; Carotid Stenosis; Cerebrum; Clinical; Clinical Trials; Cognition; Combined Modality Therapy; Dementia; Disease; Double-Blind Method; Embolism; End Point; Enrollment; Event; Hispanic Americans; Hypertension; Hypotension; Impaired cognition; Intervention; Ischemic Stroke; Label; Lead; Not Hispanic or Latino; Outcome; Participant; Patients; Pilot Projects; Population; Randomized; Randomized Controlled Clinical Trials; Range; Rate; Recurrence; Research Personnel; Risk; Risk Factors; Risk Reduction; Secondary Prevention; Source; Stroke; Stroke prevention; Survivors; Testing; Vascular Dementia; base; blood pressure regulation; clinical research site; clopidogrel; design; follow-up; nervous system disorder; programs; response

Small subcortical strokes (S3) are an important stroke subtype that account for about 25% of all ischemic strokes. In Hispanic Americans, S3 are the most frequent stroke subtype and occur at a relatively young age. S3 are usually due to cerebral small artery disease, a common substrate for vascular dementia. Over two million survivors of S3 are at high risk for recurrent stroke and for vascular dementia; millions more suffer subclinical S3 and cognitive decline caused by cerebral small artery disease. Secondary Prevention of Small Subcortical Strokes (SPS3) consists of two randomized, multicenter clinical trials that follow a 3 year NINDS-sponsored pilot study. It will enroll 2500 participants (20% of whom will be Hispanic Americans) with symptomatic, MRI-defined $3 without carotid stenosis or major cardiac sources of embolism at 35 clinical sites. Patients will be assigned, in a factorial design, to two interventions: 1. Antiplatelet Intervention 325 mg/d vs aspirin 325 mg/d plus clopidogrel 75 mg/d. 2. Blood Pressure Intervention: systolic blood pressure targets of 130 to 149 mmHg vs <130 mmHg. The antiplatelet comparison will be double-blinded, while the blood pressure intervention will open-label with blinded assessment and verification of cognition and clinical events. Follow-up will be every three months for a mean of 3 years. Main outcomes are: 1. recurrent stroke (ischemic and hemorrhagic) 2. cognitive decline 3. major vascular events Key hypotheses are: 1. Combination antiplatelet therapy is more efficacious than aspirin alone for prevention of stroke recurrence and for reduction in cognitive decline. 2. Intensive blood pressure control is associated with fewer recurrent strokes and reduction in cognitive decline. 3. The absolute reduction in stroke and cognitive decline by combined antiplatelet therapy and (separately) by intensive blood pressure lowering is greater for Hispanic Americans vs. non Hispanic white participants. 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 in Hispanic Americans. The results of SPS3 will likely lead to important reduction in the burden of serious neurological disease (stroke and vascular dementia) for millions of people with S3, and particularly for Hispanic Americans.

小皮质下中风 (S3) 是一种重要的中风亚型，约占所有缺血性中风的 25%。在西班牙裔美国人中，S3 是最常见的中风亚型，并且发生的年龄相对较小。 S3 通常是由于脑小动脉疾病引起的，这是血管性痴呆的常见原因。超过 200 万 S3 幸存者面临复发性中风和血管性痴呆的高风险；还有数百万人患有亚临床 S3 和认知能力下降 脑小动脉疾病。小皮质下中风的二级预防 (SPS3) 由两项随机、多中心临床试验组成，这些试验是在 NINDS 资助的为期 3 年的试点研究之后进行的。它将在 35 个临床中心招募 2500 名参与者（其中 20% 是西班牙裔美国人），这些参与者有症状，MRI 定义为 3 美元，无颈动脉狭窄或主要心脏栓塞来源。在因子设计中，患者将被分配接受两种干预措施： 1. 抗血小板干预 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 mmHg vs <130 mmHg。 抗血小板比较将是双盲的，而血压干预将是开放标签的，对认知和临床事件进行盲法评估和验证。每三个月进行一次随访，平均为期 3 年。 主要成果是： 1.复发性中风（缺血性和出血性） 2.认知能力下降 3.重大血管事件 主要假设是： 1. 联合抗血小板治疗比单独使用阿司匹林更能有效预防中风复发和减少认知能力下降。 2. 强化血压控制与减少中风复发和认知能力下降有关。 3. 与非西班牙裔白人参与者相比，联合抗血小板治疗和（单独）强化降压治疗对中风和认知能力下降的绝对减少幅度更大。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，或中风和痴呆的预防。 西班牙裔美国人。 SPS3 的结果可能会大大减轻数百万 S3 患者，特别是西班牙裔美国人的严重神经系统疾病（中风和血管性痴呆）的负担。