AFRICAN AMERICAN ANTIPLATELET STROKE PREVENTION STUDY (AAASPS)

非裔美国人抗血小板中风预防研究 (AAAPSS)

• 批准号: 6265910
• 负责人: ANNAPURNI JAYAM TROUTH
• 金额: $ 20.62万
• 依托单位: HOWARD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265910
• 关键词: African American; aspirin; cardiovascular disorder epidemiology; cardiovascular disorder prevention; clinical research; human subject; human therapy evaluation; platelet aggregation inhibitors; stroke

This is a phase IV, multicenter, double-blind clinical trial to compare the efficacy and safety of Ticlopidine and Aspirin among African American non-cardioembolic ischemic stroke patients with mild or moderate neurological deficits. Stroke is one of the diseases that disproportionately afflicts African Americans (African Americans are about 2.5 times more likely to die of stroke or experience stroke , as compared to their white counterparts). Preliminary studies on nonwhite, predominantly African American cerecral ischemia patients suggest that Ticlopidine hydrochloride, an FDA approved and commercially available antiplatelet agent is more effective than aspirin in the prevention of stroke and death among nonwhite patients. Thus, the Specific Aim of this study is to compare the primary outcome endpoints of recurrent stroke, myocardial infarction and vascular deaths among two treatment groups (one group randomized to aspirin therapy and the other randomized to ticlopidine therapy) of African American stroke patients. The study is designed to assess the efficacy and safety of both drugs on stroke treatment and prevention in the population studied.

这是一项IV期、多中心、双盲临床试验，目的是比较噻氯匹定和阿司匹林在有轻度或中度神经功能缺陷的非裔美国人非心源性缺血性中风患者中的疗效和安全性。中风是非洲裔美国人不成比例地受到影响的疾病之一(与白人相比，非洲裔美国人死于中风或经历中风的可能性约高2.5倍)。对非白人、主要是非裔美国人的脑缺血患者的初步研究表明，在非白人患者中，盐酸噻氯匹定是一种FDA批准的商用抗血小板药物，在预防中风和死亡方面比阿司匹林更有效。因此，这项研究的具体目的是比较非裔美国人中风患者的两组治疗(一组随机接受阿司匹林治疗，另一组随机接受噻氯匹定治疗)复发性中风、心肌梗死和血管死亡的主要结局终点。这项研究旨在评估这两种药物在研究人群中治疗和预防中风的有效性和安全性。