| Title: |
Rivaroxaban for stroke patients with antiphospholipid syndrome (RISAPS): protocol for a randomized controlled, phase IIb proof-of-principle trial |
| Authors: |
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 |
| Publisher Information: |
Elsevier |
| Publication Year: |
2024 |
| Collection: |
St George's University of London: Repository |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf; application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Language: |
English |
| ISSN: |
2475-0379 |
| Relation: |
https://openaccess.sgul.ac.uk/id/eprint/116738/1/RISAPS%202024.pdf; https://openaccess.sgul.ac.uk/id/eprint/116738/6/1-s2.0-S2475037924001572-mmc1.docx; 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 |
| DOI: |
10.1016/j.rpth.2024.102468 |
| Availability: |
https://openaccess.sgul.ac.uk/id/eprint/116738/; https://openaccess.sgul.ac.uk/id/eprint/116738/1/RISAPS%202024.pdf; https://doi.org/10.1016/j.rpth.2024.102468 |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.D8F6BBCB |
| Database: |
BASE |