Mittal, P;
Gafoor, R;
Sayar, Z;
Efthymiou, M;
Tohidi-Esfahani, I;
Appiah-Cubi, S;
Arachchillage, DJ;
Atkinson, D;
Bordea, E;
Cardoso, MJ;
et al.
Mittal, P; Gafoor, R; Sayar, Z; Efthymiou, M; Tohidi-Esfahani, I; Appiah-Cubi, S; Arachchillage, DJ; Atkinson, D; Bordea, E; Cardoso, MJ; Caverly, E; Chandratheva, A; Chau, M; Freemantle, N; Gates, C; Jager, HR; Kaul, A; Mitchell, C; Nguyen, H; Packham, B; Paskell, J; Patel, JP; Round, C; Sanna, G; Zaidi, A; Werring, DJ; Isenberg, D; Cohen, H
(2024)
Rivaroxaban for stroke patients with antiphospholipid syndrome (RISAPS): protocol for a randomized controlled, phase IIb proof-of-principle trial.
RESEARCH AND PRACTICE IN THROMBOSIS AND HAEMOSTASIS, 8 (5).
p. 102468.
ISSN 2475-0379
https://doi.org/10.1016/j.rpth.2024.102468
SGUL Authors: Kaul, Arvind
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Abstract
Background Optimal secondary prevention antithrombotic therapy for patients with antiphospholipid syndrome (APS)-associated ischemic stroke, transient ischemic attack, or other ischemic brain injury is undefined. The standard of care, warfarin or other vitamin K antagonists at standard or high intensity (international normalized ratio (INR) target range 2.0-3.0/3.0-4.0, respectively), has well-recognized limitations. Direct oral anticoagulants have several advantages over warfarin, and the potential role of high-dose direct oral anticoagulants vs high-intensity warfarin in this setting merits investigation. Objectives The Rivaroxaban for Stroke patients with APS trial (RISAPS) seeks to determine whether high-dose rivaroxaban could represent a safe and effective alternative to high-intensity warfarin in adult patients with APS and previous ischemic stroke, transient ischemic attack, or other ischemic brain manifestations. Methods This phase IIb prospective, randomized, controlled, noninferiority, open-label, proof-of-principle trial compares rivaroxaban 15 mg twice daily vs warfarin, target INR range 3.0-4.0. The sample size target is 40 participants. Triple antiphospholipid antibody-positive patients are excluded. The primary efficacy outcome is the rate of change in brain white matter hyperintensity volume on magnetic resonance imaging, a surrogate marker of presumed ischemic damage, between baseline and 24 months follow-up. Secondary outcomes include additional neuroradiological and clinical measures of efficacy and safety. Exploratory outcomes include high-dose rivaroxaban pharmacokinetic modeling. Conclusion Should RISAPS demonstrate noninferior efficacy and safety of high-dose rivaroxaban in this APS subgroup, it could justify larger prospective randomized controlled trials.
Item Type: | Article | |||||||||
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Additional Information: | © 2024 The Author(s). Published by Elsevier Inc. on behalf of International Society on Thrombosis and Haemostasis. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). | |||||||||
Keywords: | antiphospholipid syndrome, ischemic stroke, rivaroxaban, thrombosis, warfarin | |||||||||
SGUL Research Institute / Research Centre: | Academic Structure > Institute of Medical & Biomedical Education (IMBE) Academic Structure > Institute of Medical & Biomedical Education (IMBE) > Centre for Clinical Education (INMECE ) |
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Journal or Publication Title: | RESEARCH AND PRACTICE IN THROMBOSIS AND HAEMOSTASIS | |||||||||
ISSN: | 2475-0379 | |||||||||
Dates: |
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Publisher License: | Creative Commons: Attribution 4.0 | |||||||||
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Web of Science ID: | WOS:001281930100001 | |||||||||
URI: | https://openaccess.sgul.ac.uk/id/eprint/116738 | |||||||||
Publisher's version: | https://doi.org/10.1016/j.rpth.2024.102468 |
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