Pengo V, Banzato A, Bison E, Zoppellaro G, Padayattil Jose S, Denas G
Clinical Cardiology, Thrombosis Centre, Department of Cardiac Thoracic and Vascular Sciences, University of Padova School of Medicine, Padova, Italy
Clinical Cardiology, Thrombosis Centre, Department of Cardiac Thoracic and Vascular Sciences, University of Padova School of Medicine, Padova, Italy.
Lupus. 2016 Mar;25(3):301-6. doi: 10.1177/0961203315611495. Epub 2015 Oct 13.
New oral anticoagulants may simplify long-term therapy in conditions requiring anticoagulation. Rivaroxaban is a direct factor Xa inhibitor that has been extensively studied and is now approved for the prevention and therapy of a number of thromboembolic conditions.
This is a multicentre, randomized, open-label, study that will evaluate if Rivaroxaban 20 mg od (or 15 mg od in patients with moderate renal insufficiency) is non-inferior to warfarin (INR target 2.5), for the prevention of thromboembolic events, major bleeding and death in high risk (triple positive) patients with antiphospholipid syndrome. Secondary endpoints will assess the incidence of any individual component of the composite end point. An external adjudication committee will evaluate all suspected outcome events. This will be a unique trial, as it will enrol the biggest homogenous cohort of high risk APS individuals.
The methods and the study design should be appropriate to achieve study results that are both scientifically valid and relevant to clinical practice.
新型口服抗凝剂可能会简化需要抗凝治疗的长期治疗方案。利伐沙班是一种直接Xa因子抑制剂，已得到广泛研究，目前已被批准用于多种血栓栓塞性疾病的预防和治疗。
这是一项多中心、随机、开放标签的研究，旨在评估利伐沙班20mg每日一次（中度肾功能不全患者为15mg每日一次）在预防抗磷脂综合征高危（三项阳性）患者发生血栓栓塞事件、大出血和死亡方面是否不劣于华法林（国际标准化比值目标值为2.5）。次要终点将评估复合终点中任何单个组成部分的发生率。一个外部判定委员会将评估所有可疑的结局事件。这将是一项独特的试验，因为它将纳入最大的高危抗磷脂综合征个体同质队列。
这些方法和研究设计应适合得出科学有效且与临床实践相关的研究结果。
