Warfarin vs Aspirin in Reduced Ejection Fraction -STAT

WARCEF-STAT和WARCEF-CLIN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（目标入组70家临床研究中心的2860例患者） 旨在检验华法林（INR 2.5-3，目标值2.75）和阿司匹林（325）之间无差异的主要零假设 对于复合终点死亡或卒中或脑出血， 低（<=30%）心脏左心室射血分数（LVEF）。对预先规定的次要假设进行检验， 女性和非裔美国人的亚组，以及单独的卒中终点。预先规定的第三假设是 通过合并来自WARCEF和另一项试验（WATCH）的数据进行测试。WARCEF-STAT的目标是：1） 进行，有效整合，并负责所有WARCEF数据管理，双盲，药物 管理、质量控制和报告业务。2)规定、实施并负责所有临时、安全、 和最终统计分析，并报告这些结果。3)传送给临床协调 中心（CCC）及时提供所有的数据，WARCEF-CLIN的主要研究者需要满足他的 在确保患者安全和指导所有临床操作方面的职责。目标1的实现是 整合一个在心脏试验方面具有丰富经验的数据管理中心和一个 正在进行的华法林-阿司匹林双盲研究（WARSS）。双盲算法用于 将针对WARCEF目标范围重新校准和重新验证WARSS，以确定接受活性阿司匹林治疗的患者的INR 在战争开始之前。目标2由在中风、心脏病和其他方面经验丰富的统计分析部门实现 临床试验目标3由WARCEF-STAT和WARCEF-CLIN调查员组成的行动委员会确保， 高级协调员在严格规定和控制的通信协议下经常开会。

WARCEF-STAT and WARCEF-CLIN are two separate but highly coordinated units which together constitute WARCEF, a two-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, target 2.75) and aspirin (325 mg/day) in 3-5 year survival for the composite endpoint death or stroke or intracerebral hemorrhage among patients with low (<=30%) cardiac Left Ventricular Ejection Fraction (LVEF). Prespecified secondary hypotheses are tested for subgroups of women and African Americans, and for the endpoint of stroke alone. Prespecified tertiary hypotheses are tested by amalgamating data from WARCEF and another trial (WATCH). The goals of WARCEF-STAT are: 1) to conduct, efficiently integrate, and be responsible for all WARCEF data management, double-blinding, medication management, quality control, and reporting operations. 2) to specify, conduct and be responsible for all interim, safety, and final statistical analyses for WARCEF and for the reporting of these results. 3) to transmit to the Clinical Coordinating Center (CCC) in a timely fashion all of the data which the principal investigator of WARCEF-CLIN needs to meet his responsibilities in terms of ensuring patient safety and directing all clinical operations. Goal 1 is accomplished by integrating a Data Management Center with substantial experience in cardiac trials and an anticoagulation unit which is successfully conducting an ongoing double blind warfarin-aspirin study (WARSS). The double-blind algorithm used in WARSS to fabricate INRs for patients on active aspirin will be recalibrated and revalidated for the WARCEF target range before WARCEF begins. Goal 2 is achieved by a statistical analysis unit that is experienced in stroke, cardiac, and other clinical trials. Goal 3 is ensured by an Operations Committee of WARCEF-STAT and WARCEF-CLIN investigators and senior coordinators which meets frequently under tightly specified and controlled communication protocols.