Table 1 Studies included in the CALLISTO programmea
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 |