Rivaroxaban versus warfarin to treat patients with thrombotic antiphospholipid syndrome, with or without systemic lupus erythematosus (RAPS): a randomised, controlled, open-label, phase 2/3, non-inferiority trial Dr Hannah Cohen, MD, Prof Beverley J Hunt, MD, Maria Efthymiou, PhD, Deepa R J Arachchillage, MD, Ian J Mackie, PhD, Simon Clawson, BSc, Yvonne Sylvestre, MSc, Prof Samuel J Machin, FRCP, Maria L Bertolaccini, PhD, Maria Ruiz-Castellano, MD, Nicola Muirhead, PhD, Prof Caroline J Doré, BSc, Prof Munther Khamashta, MD, Prof David A Isenberg, MD The Lancet Haematology Volume 3, Issue 9, Pages e426-e436 (September 2016) DOI: 10.1016/S2352-3026(16)30079-5 Copyright © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license Terms and Conditions
Figure 1 Trial profile LLOD=lower limit of detection. The Lancet Haematology 2016 3, e426-e436DOI: (10.1016/S2352-3026(16)30079-5) Copyright © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license Terms and Conditions
Figure 2 Thrombin generation parameters at baseline (left) and day 42 (right) Solid lines indicate medians, dotted lines indicate limits of normal ranges. NR=normal range. Warfarin (W)=patients receiving warfarin at baseline who continued taking warfarin after randomisation. Warfarin (R)=patients receiving warfarin at baseline who were switched to rivaroxaban at randomisation. The Lancet Haematology 2016 3, e426-e436DOI: (10.1016/S2352-3026(16)30079-5) Copyright © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license Terms and Conditions
Figure 3 Thrombograms for median (25th and 7th percentiles) ETP values in RAPS, compared with a typical normal control value (A) Patients taking warfarin. (B) Patients taking rivaroxaban. ETP=endogenous thrombin potential. RAPS=the Rivaroxaban in Antiphospholipid Syndrome trial. The Lancet Haematology 2016 3, e426-e436DOI: (10.1016/S2352-3026(16)30079-5) Copyright © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license Terms and Conditions