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Rivaroxaban in antiphospholipid syndrome (RAPS) protocol: a prospective, randomized controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE.

Authors
  • Cohen, H1
  • Doré, C J2
  • Clawson, S2
  • Hunt, B J3
  • Isenberg, D4
  • Khamashta, M5
  • Muirhead, N2
  • 1 Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK Haemostasis Research Unit, Department of Haematology, University College London, London, UK [email protected]
  • 2 University College London Comprehensive Clinical Trials Unit, Gower Street, London, UK.
  • 3 Department of Haematology, Guy's and St Thomas' NHS Foundation Trust, London, UK Department of Haematology, Kings College London, London, UK.
  • 4 Centre for Rheumatology Research, Division of Medicine, University College London, London, UK.
  • 5 Department of Rheumatology, Guy's and St Thomas' NHS Foundation Trust, London, UK Department of Rheumatology, Kings College London, London, UK.
Type
Published Article
Journal
Lupus
Publisher
SAGE Publications
Publication Date
Sep 01, 2015
Volume
24
Issue
10
Pages
1087–1094
Identifiers
DOI: 10.1177/0961203315581207
PMID: 25940537
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

The current mainstay of the treatment of thrombotic antiphospholipid syndrome (APS) is long-term anticoagulation with vitamin K antagonists (VKAs) such as warfarin. Non-VKA oral anticoagulants (NOACs), which include rivaroxaban, have been shown to be effective and safe compared with warfarin for the treatment of venous thromboembolism (VTE) in major phase III prospective, randomized controlled trials (RCTs), but the results may not be directly generalizable to patients with APS. The primary aim is to demonstrate, in patients with APS and previous VTE, with or without systemic lupus erythematosus (SLE), that the intensity of anticoagulation achieved with rivaroxaban is not inferior to that of warfarin. Secondary aims are to compare rates of recurrent thrombosis, bleeding and the quality of life in patients on rivaroxaban with those on warfarin. Rivaroxaban in antiphospholipid syndrome (RAPS) is a phase II/III prospective non-inferiority RCT in which eligible patients with APS, with or without SLE, who are on warfarin, target international normalized ratio (INR) 2.5 for previous VTE, will be randomized either to continue warfarin (standard of care) or to switch to rivaroxaban. Intensity of anticoagulation will be assessed using thrombin generation (TG) testing, with the primary outcome the percentage change in endogenous thrombin potential (ETP) from randomization to day 42. Other TG parameters, markers of in vivo coagulation activation, prothrombin fragment 1.2, thrombin antithrombin complex and D-dimer, will also be assessed. If RAPS demonstrates i) that the anticoagulant effect of rivaroxaban is not inferior to that of warfarin and ii) the absence of any adverse effects that cause concern with regard to the use of rivaroxaban, this would provide sufficient supporting evidence to make rivaroxaban a standard of care for the treatment of APS patients with previous VTE, requiring a target INR of 2.5. © The Author(s) 2015.

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