AFRICAN AMERICAN ANTIPLATELET STROKE PREVENTION STUDY

非裔美国人抗血小板中风预防研究

• 批准号: 6152482
• 负责人: PHILIP B GORELICK
• 金额: $ 35.18万
• 依托单位: RUSH UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-07-01 至 2000-09-24
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6152482
• 关键词: African American; aspirin; cardiovascular disorder epidemiology; cardiovascular disorder prevention; chemoprevention; clinical trials; drug adverse effect; human subject; human therapy evaluation; longitudinal human study; platelet aggregation inhibitors; relapse /recurrence; stroke

Stroke is one of the important diseases that disproportionately affect African-Americans. African-American men and women are about 2.5 times more likely than whites to die of cerebrovascular disease or experience stroke. Scientific information about the efficacy and safety of stroke preventatives in this group is much needed, yet African-Americans and other minorities have been underrepresented in biomedical research studies. Preliminary data collected from nonwhite, predominantly African- American patients, suggest that ticlopidine is more effective than aspirin in the secondary prevention of stroke and death, and the risk of serious adverse events is low. This is a proposal for a multicenter, randomized, double-blind clinical trial of ticlopidine hydrochloride (500mg/day) and aspirin (1300mg/day) in African-American patients with recent non-cardioembolic ischemic stroke. The primary purpose of the study is to test the efficacy of ticlopidine and aspirin in the prevention of the outcome endpoints recurrent stroke, vascular death and myocardial infarction in these African-American patients. Adverse experiences will be studied to further our understanding of the safety of these medications in this group. The study will be conducted in the Chicago area at 18 sites experienced in the diagnosis and treatment of stroke. 1800 patients will be enrolled over 3- 4 years, and each will be followed for at least 2 years. Patients will be randomly assigned to treatment at least 7 days but no more than 90 days after cerebral infarction. The trial promises to provide much needed information about secondary stroke prevention in African-Americans and has the support of established African-American physician, church-based and community organizations in Chicago. Enrollment of a substantial number of African-American women is anticipated. Data from these patients will significantly add to our understanding of cerebrovascular disease among black women. Furthermore, the study could also serve as an organizational framework for future studies of stroke prevention or hyperacute treatment in the Chicago area.

中风是一种重要的疾病， 非裔美国人非洲裔美国男性和女性约为2.5倍 比白人更容易死于脑血管疾病或中风。 关于中风的疗效和安全性的科学信息 在这个群体中预防艾滋病是非常必要的，但非洲裔美国人和 其他少数民族在生物医学研究中的代表性不足 问题研究 从非白人，主要是非洲人收集的初步数据- 美国患者，建议噻氯匹定比阿司匹林更有效 在中风和死亡的二级预防中， 不良事件发生率低。 这是一项多中心、随机、双盲临床试验的建议， 盐酸噻氯匹定（500 mg/天）和阿司匹林（1300 mg/天）在中的试验 近期发生非心源性栓塞性缺血性卒中的非裔美国患者。 该研究的主要目的是测试噻氯匹定的疗效 和阿司匹林在预防结局终点复发性卒中中的作用， 非裔美国人的血管性死亡和心肌梗死 患者 将研究不良经历， 了解这些药物在该组中的安全性。研究 将在芝加哥地区的18个研究中心进行， 中风的诊断和治疗。 将招募1800名患者，年龄超过3- 4年，每项研究将随访至少2年。患者将 随机分配治疗至少7天但不超过90天 脑梗塞后。 该试验承诺提供急需的信息， 在非洲裔美国人中预防中风， 非洲裔美国医生、教会和社区组织 芝加哥。大量非洲裔美国妇女的入学率是 预期的。 这些患者的数据将大大增加我们的 了解黑人女性的脑血管疾病此外，委员会认为， 这项研究还可作为今后工作组织框架 芝加哥地区中风预防或超急性治疗的研究。