Warfarin vs Aspirin in Reduced Ejection Fraction-CLIN

华法林与阿司匹林在射血分数降低方面的比较-CLIN

• 批准号: 7405642
• 负责人: Shunichi Homma
• 金额: $ 194.66万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2007-09-20
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7405642
• 关键词: Address; African American; Algorithms; American; Aspirin; Atrial Fibrillation; Cardiac; Cardiovascular system; Cerebral hemisphere hemorrhage; Cerebrum; Cessation of life; Chronic; Class; Clinical; Data; Dose; Double-Blind Method; EFRAC; Echocardiography; End Point; Enrollment; Equilibrium; Etiology; Functional disorder; Goals; Heart Diseases; Heart failure; Infarction; International Normalized Ratio; Intervention; Ischemic Stroke; Left; Left Ventricular Dysfunction; Link; Medicine; Motion; Myocardial Ischemia; Numbers; Patients; Public Health; Randomized; Rate; Recurrence; Relative (related person); Relative Risks; Research; Research Personnel; Risk; Risk Factors; Risk Reduction; Sample Size; Side; Stroke; Subgroup; Telephone; Testing; Time; Upper arm; Ventricular; Warfarin; Woman; clinical research site; cognitive function; day; design; follow-up; hazard; indexing; men; mortality; older patient; prevent

Heart failure is one of the most important public health problems in cardiovascular medicine. There are 4.7 million Americans with heart failure and 400,000 new cases each year with 250,000 deaths and 75,000 strokes per year attributable to heart failure. Cardiac Ejection Fraction (EF) is a gooc index of left ventricular dysfunction and low EF (¿30%) is a risk factor for stroke in patients with cardiac failure. WARCEF-CLIN and WARCEF-STAT are two separate but highly coordinated units which together constitute WARCEF, a two-arm (1:1) double blind randomized multicenter clinical tria (target enrollment 2860 patients at 70 clinical sites) designed to test the primary null hypothesis of nc difference between warfarin (INR 2.5-3) and aspirin (325 mg) in 3-5 year survival for the composite endpoint death or recurrent stroke or intracerebral hemorrhage among patients with low EF, Secondary hypotheses are to be tested for subgroups of women and African Americans, and for the endpoint of stroke alone. Patients with low EF by quantitative assessment or with a wall motion index <1 by echocardiography will be randomized to warfarin or aspirin. The dose of warfarin will be adjusted to keep the INR between 2.5 to 3 with a target INR of 2.75, using a double blind algorithm to fabricate INRs for patients on active aspirin has been used successfully in a multicenter warfarin- aspirin study (WARSS). Patients will be contacted monthly by phone and examined every four months over a mean follow up of 3 years to determine whether any endpoints have occurred. The study will define optimal antithrombotic therapy for patients with cardiac failure and patients with low EF. With the rapidly increasing numbers of elderly patients with cardiac failure, the study ha important public health implications. Our long term goals are to study antithrombotic therapy cardiac disease giving rise to stroke.

心力衰竭是心血管医学中最重要的公共健康问题之一。那里 有470万美国人患有心力衰竭，每年新增40万例，死亡25万人 每年有75,000例中风可归因于心力衰竭。心脏射血分数(EF)是一个很好的指标 左心功能不全指数和低EF(？30%)是高血压患者卒中的危险因素 心力衰竭。WARCEF-CLIN和WARCEF-STAT是两个独立但高度协调的单元 它们共同构成了WARCEF，一项双臂(1：1)双盲随机多中心临床试验 (70个临床站点的2860名患者的目标登记)旨在测试NC的原始零假设 华法林(INR 2.5-3)与阿司匹林(325 Mg)在复方制剂3-5年生存率中的差异 低EF患者的终点死亡或复发中风或脑出血， 次要假设将在女性和非裔美国人的亚群中进行测试，并在 仅为中风的终点。定量评估EF低或室壁运动指数低的患者 &lt；1超声心动图将被随机分为华法林或阿司匹林。华法林的剂量将是 调整为将INR保持在2.5到3之间，目标INR为2.75，使用双盲算法 为服用活性阿司匹林的患者制造INR已成功用于多中心华法林- 阿司匹林研究(WARSS)。每月将通过电话与患者联系，并每四次检查一次 3个月，平均随访3年，以确定是否发生任何终点。这个 研究将确定心力衰竭患者和低血压性心脏病患者的最佳抗血栓治疗 EF.随着老年心力衰竭患者数量的迅速增加，这项研究已经 对公共卫生的重要影响。我们的长期目标是研究抗血栓疗法 引起中风的心脏病。