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Table 1 Studies included in the CALLISTO programmea

From: COSIMO – patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study

Study name Study designand patient population Dose Clinical trial reference Status
VTE prevention
 CASSINI Prospective, randomised, double-blind, placebo-controlled superiority analysis in patients at high risk of VTE due to initiate chemotherapy for cancer Rivaroxaban 10 mg od for 6 months NCT02555878 Ongoing
 PRO-LAPS 2 IIR Randomised, double-blind, placebo-controlled study of extended antithrombotic prophylaxis in patients after laparoscopic surgery for colorectal cancer Rivaroxaban 10 mg od for 28 days with 2 months of follow-up NCT03055026 Ongoing
VTE treatment
 select-d IIR Randomised, open-label, multicentre pilot study, with a second placebo-controlled randomisation, comparing the duration of anticoagulation therapy (6 months vs 12 months) in adult patients with residual vein thrombosis Dalteparin (200 IU/kg od for the first 30 days, followed by 150 IU/kg od) Rivaroxaban (15 mg bid for 21 days, followed by 20 mg od) EudraCT 2012-005589-37 Results reported [20]
 CASTA-DIVA IIR Randomised, open-label pilot study in patients with active cancer and confirmed acute VTE Dalteparin 200 IU/kg od for 4 weeks, followed by 150 IU/kg od for 8 weeks Rivaroxaban 15 mg bid for 3 weeks, followed by 20 mg od for 9 weeks NCT02746185 Ongoing
 CONKO-011 IIR Prospective, randomised, open-label, multicentre study in patients with active cancer and confirmed acute VTE LMWH as per label for 3 months Rivaroxaban 15 mg bid for 21 days, followed by 20 mg od for 3 months NCT02583191 Ongoing
 Investigator- initiated quality assessment initiative Follow-up of 200 patients with cancer-associated thrombosis who previously received rivaroxaban for 6 months Rivaroxaban 15 mg bid for 3 weeks, then 20 mg od (reduced in patients aged >75 years) N/A Results reported [36]
 COSIMO Patient-reported outcomes, follow-up for 6 months Rivaroxaban as per label NCT02742623 Ongoing
 FRONTLINE 2 surveyc Second non-interventional study of current practice in the treatment of cancer-associated thrombosis. Up to 5000 oncologists and haematologists will be surveyed N/A N/A Ongoing
  1. aPlease see https://www.xarelto.com/en/resources/newsfeed/bayer-extends-clinical-investigation-of-xarelto-for-the-prevention-and-treatment-of-life-threatening-blood-clots-in-patients-with-cancer/ (accessed 19 Jun. 2018) for information about the CALLISTO programme. bPlease see http://frontline2.tri-london.ac.uk/ for information on the FRONTLINE 2 survey
  2. bid, twice daily; IIR investigator-initiated research, LMWH low molecular weight heparin, N/A not applicable, od once daily, VTE venous thromboembolism