AFRICAN AMERICAN ANTIPLATELET STROKE PREVENTION STUDY

非裔美国人抗血小板中风预防研究

• 批准号: 2696722
• 负责人: PHILIP B GORELICK
• 金额: $ 21.15万
• 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 2000-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2696722
• 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.

中风是严重影响人类健康的重要疾病之一。 非裔美国人。非洲裔美国人的男性和女性大约是 比白人更有可能死于脑血管疾病或中风。 有关中风疗效和安全性的科学信息 这一群体的预防措施非常需要，但非洲裔美国人和 其他少数群体在生物医学研究中的代表性不足。 学习。初步数据来自非白人，主要是非洲人- 美国患者表示，噻氯匹定比阿司匹林更有效 在二级预防中风和死亡方面，严重的风险 不良事件很少。 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/d)和阿司匹林(1300 mg/d)的临床试验 近期非心源性缺血性中风的非裔美国人患者。 这项研究的主要目的是测试噻氯匹定的疗效 阿司匹林在预防终点复发卒中的结局中， 这些非裔美国人的血管死亡和心肌梗死 病人。将对不良经历进行研究，以进一步 了解这些药物在本组中的安全性。这项研究 将在芝加哥地区的18个地点进行，经验丰富 中风的诊断和治疗。1800名患者将在3- 4年，每一次都将被跟踪至少2年。病人将会是 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有关次要疾病的信息。 在非裔美国人中预防中风，并得到了已建立的 非裔美国医生、教会和社区组织 芝加哥。大量非裔美国女性的入学人数是 已经预料到了。来自这些患者的数据将显著增加我们的 黑人女性对脑血管疾病的了解。此外， 这项研究还可以作为今后的组织框架 芝加哥地区中风预防或超急性治疗的研究。