WARFARIN VS ASPIRIN IN REDUCED CARDIAC EJECTION FRACTION

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。心脏射血分数（EF）是左心室功能障碍的良好指标，低EF（低于30%）是心力衰竭患者发生卒中的风险。该研究是一项2组、1:1双盲随机多中心临床试验（目标纳入70个临床站点的2860例患者），旨在检验华法林（INR 2.5-3.0）和阿司匹林（325 mg）在低EF患者中3-5年生存率无差异的主要零假设，以死亡或复发性卒中或脑出血为复合终点。次要假设将在妇女和非裔美国人的亚组中进行测试，并且仅针对中风的终点。定量评估EF低或超声心动图壁运动指数小于1的患者将随机分配华法林或阿司匹林。将调整华法林的剂量，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捏造INR。在平均3年的随访中，每月通过电话联系患者，每4个月检查一次，以确定是否有任何终点发生。该研究将确定心力衰竭患者和低EF患者的最佳抗血栓治疗方法。

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.