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Publication Detail
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
  • Publication Type:
    Journal article
  • Publication Sub Type:
    Article
  • Authors:
    Clawson SM, Cohen H, Dore C, Hunt B, Isenberg D, Khamashta M, Muirhead N
  • Publisher:
    Sage Journals
  • Publication date:
    09/2015
  • Pagination:
    1087, 1094
  • Journal:
    Lupus
  • Volume:
    24
  • Issue:
    10
  • Status:
    Accepted
  • Country:
    UK
  • Print ISSN:
    0961-2033
  • Addresses:
    Department of Haematology, University College London Hospitals NHS Foundation Trust
    London

    Haemostasis Research Unit, Department of Haematology, University College London
    London

    University College London Comprehensive Clinical Trials Unit
    London

    Departments of Hematology and Rheumatology, Guy’s and St Thomas’ NHS Foundation Trust
    London

    Centre for Rheumatology Research, Division of Medicine, University College London
    London
Abstract
Introduction The current mainstay of the treatment of thrombotic antiphospholipid syndrome (APS) is long-term anticoagulation with vitamin K antagonists (VKA) such as warfarin. Non-VKA oral anticoagulants (NOAC), 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 randomised controlled trials (RCT), but the results may not be directly generalisable to patients with APS. Aims 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. Methods 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 Normalised Ratio (INR) 2.5 for previous VTE, will be randomised 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 endogenous thrombin potential (ETP) as the key parameter. The primary outcome is the percentage change in ETP from randomisation to day 42. Markers of in vivo coagulation activation, prothrombin fragment 1.2, thrombin antithrombin complex and D-dimer, will also be measured. Discussion If RAPS demonstrates that i) that the anticoagulant effect of rivaroxaban is not inferior to that of warfarin using TG testing 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.
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