WARFARIN VS ASPIRIN IN REDUCED CARDIAC EJECTION FRACTION

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。心脏射血分数(EF)是反映左心功能不全的良好指标，低EF(<30%)是心力衰竭患者发生卒中的危险因素。这项研究是一项双臂、1：1双盲随机多中心临床试验(目标招募70个临床地点的2860名患者)，旨在测试华法林(INR 2.5-3.0)和阿司匹林(325 Mg)在低EF患者中死亡或复发中风或脑出血的复合终点在3-5年生存中没有差异的原始零假设。次级假设将在女性和非裔美国人的亚群中进行测试，并仅针对中风的终点进行测试。定量评估EF低或超声心动图室壁运动指数小于1的患者将随机服用华法林或阿司匹林。华法林的剂量将被调整，使INR保持在2.5至3.0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。患者将每月通过电话联系，并在平均3年的随访中每4个月检查一次，以确定是否发生了任何终点。这项研究将确定心力衰竭患者和低EF患者的最佳抗血栓治疗。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Cardiac ejection fraction (EF) is a good index of left ventricular dysfunction and low EF (less than 30%) is a risk for stroke in patients with cardiac failure. This study is a 2 arm, 1:1 double blind randomized multicenter clinical trial (target enrollment 2860 patients at 70 clinical sites) designed to test the primary null hypothesis of no difference between warfarin (INR 2.5-3.0) and aspirin (325 mg) in 3-5 year survival for the composite endpoint of 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 less than 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 3.0 with a target INR of 2.75, using a double-blind algorithm to fabricate INRs for patients on active aspirin. 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.