Please use this identifier to cite or link to this item:
http://hdl.handle.net/1942/26477
Title: | Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study | Authors: | Windecker, Stephan Tijssen, Jan Giustino, Gennaro Guimaraes, Ana H. C. Mehran, Roxana Valgimigli, Marco VRANCKX, Pascal Welsh, Robert C. Baber, Usman van Es, Gerrit-Anne Wildgoose, Peter Volkl, Albert A. Zazula, Ana Thomitzek, Karen Hemmrich, Melanie Dangas, George D. |
Issue Date: | 2017 | Source: | AMERICAN HEART JOURNAL, 184 | Abstract: | Background Optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) is unknown and determined empirically. The direct factor Xa inhibitor rivaroxaban may potentially reduce TAVR-related thrombotic complications and premature valve failure. Design GALILEO is an international, randomized, open-label, event-driven, phase III trial in more than 1,520 patients without an indication for oral anticoagulation who underwent a successful TAVR (ClinicalTrials. gov NCT02556203). Patients are randomized (1: 1 ratio), 1 to 7 days after a successful TAVR, to either a rivaroxaban-based strategy or an antiplateletbased strategy. In the experimental arm, subjects receive rivaroxaban (10 mg once daily [ OD]) plus acetylsalicylic acid (ASA, 75-100 mg OD) for 90 days followed by rivaroxaban alone. In the control arm, subjects receive clopidogrel (75 mg OD) plus ASA (as above) for 90 days followed by ASA alone. In case new-onset atrial fibrillation occurs after randomization, full oral anticoagulation will be implemented with maintenance of the original treatment assignment. The primary efficacy end point is the composite of all-cause death, stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, and systemic embolism. The primary safety end point is the composite of life-threatening, disabling, and major bleeding, according to the Valve Academic Research Consortium definitions. Conclusions GALILEO will test the hypothesis that a rivaroxaban-based antithrombotic strategy reduces the risk of thromboembolic complications post-TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy-based strategy in subjects without need of chronic oral anticoagulation. | Document URI: | http://hdl.handle.net/1942/26477 | ISSN: | 0002-8703 | e-ISSN: | 1097-6744 | DOI: | 10.1016/j.ahj.2016.10.017 | ISI #: | 000396389000012 | Rights: | © 2016 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). http://dx.doi.org/10.1016/j.ahj.2016.10.017 | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
trial.pdf | Published version | 282.99 kB | Adobe PDF | View/Open |
SCOPUSTM
Citations
73
checked on Sep 3, 2020
WEB OF SCIENCETM
Citations
73
checked on Jul 27, 2024
Page view(s)
80
checked on Jul 20, 2022
Download(s)
110
checked on Jul 20, 2022
Google ScholarTM
Check
Altmetric
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.