阿桑德西安与阿皮克萨班在患有心房的患者中
Jonathan P Piccini1, Manesh R Patel1, Jan Steffel1
1From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich, Switzerland (J.S.); the School of Medicine, Tulane University, New Orleans (K.F.); the University Medical Center, University of Groningen, Groningen (I.C.V.G., M.R.), Radboud University Medical Center, Nijmegen (M.H.), Rijnstate Hospital, Arnhem (M.H.), and the Dutch Network for Cardiovascular Research, Utrecht (M.H.) - all in the Netherlands; Cooper Medical School of Rowan University, Camden (A.M.R.), and Bayer U.S., Whippany (R.C.) - both in New Jersey; the Cardiology Center of Beijing, Anzhen Hospital No. 2, Beijing (C.-S.M.); the Canadian VIGOUR Centre, University of Alberta, Edmonton, and St. Michael's Hospital, Unity Health Toronto, and Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto - all in Canada (S.G.G.); the Uppsala Clinical Research Center and the Department of Medical Sciences, Uppsala University, Uppsala, Sweden (J.O.); the Department of Cardiology, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia (C.H.); the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan (M.A.); the School of Cardiology, University of Pisa, and the Cardiology Division, Pisa University Hospital, Pisa (R.D.C.), and Santa Maria della Misericordia Hospital, University of Perugia, Perugia (V.C.) - all in Italy; the Department of Cardiology, University Heart and Vascular Center Hamburg, and the German Center for Cardiovascular Research, Hamburg (P.K.), and Bayer, Wuppertal (C.N., T.V., H.M.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Faculty of Medicine, National Heart and Lung Institute, Imperial College, London (D.A.G.), the Centre for Health Services and Clinical Research, Faculty of Life and Medical Sciences, University of Hertfordshire, Hatfield (D.A.G.), and the Liverpool Centre for Cardiovascular Science at University of Liverpool and John Moores University and Liverpool Heart and Chest Hospital, Liverpool (G.Y.H.L.) - all in the United Kingdom; the Department of Clinical Medicine, Danish Center for Health Services Research, Aalborg University, Aalborg, Denmark (G.Y.H.L.); and Bayer, São Paulo (J. Hung).
口服抗凝剂阿桑德西安在心房患者中显示出较少的重大出血事件,但与阿皮克萨班相比,中风或全身栓塞的发病率较高. 对于中风预防的有效性需要进一步的研究.
科学领域:
- 心脏病学 心脏病学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 直接作用的口服抗凝剂 (DOAC) 用于心房动 (AF) 预防中风风险出血.
- 阿桑德西安是一种新型XIa因子抑制剂,旨在降低出血风险.
研究的目的:
- 评估阿桑德西安在预防中风或全身栓塞方面是否与阿皮克萨班不劣.
- 评估阿桑德西安在减少重大出血事件方面是否优于阿皮克萨班.
主要方法:
- 第三阶段,国际双盲试验,比较阿桑德西安 (50毫克每天一次) 与阿皮克萨班.
- 在1:1的比率上随机选择了14810名高风险的AF患者.
- 主要终点:对中风/全身栓塞没有劣势,对严重出血有优势.
主要成果:
- 审判过早停止了.
- 阿森德西安组:中风/全身血栓塞率为1.3%;阿皮克萨班组:0.4% (HR 3.79).
- 阿森德西安组:0.2%大出血;阿皮克萨班组:0.7% (HR 0.32).
结论:
- 在提前停止试验之前,阿桑德西安的中风/全身血栓发生率高于阿皮克萨班.
- 与阿皮克萨班相比,阿桑德西安显示出较少的重大出血事件.
- 该研究强调了asundexian的有效性和安全性之间的潜在权衡.
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