A115: Anticoagulation therapy in selected cancer patients at risk of recurrence of venous thromboembolism
1University of Warwick, Coventry, UK,2University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK
Venous thromboembolism (VTE) in cancer patients is an important and increasingly frequent clinical problem. The impact of VTE on cancer patients can be considerable. Targeted patient selection by identifying patients with clinically relevant recurrent VTE may have wider health economic benefits whilst reducing patient risk through over-treatment. In the UK, dalteparin is the licensed anticoagulant for the extended treatment and prevention of recurrence of VTE in cancer patients and thus, the gold standard. Rivaroxaban is a highly selective direct Factor Xa inhibitor with oral bioavailability.
Select-d is a prospective, randomised, open label, multicentre pilot trial comparing dalteparin (200 IU/kg daily subcutaneously for 1 month and 150 IU/kg months 2-6); and rivaroxaban (15 mg orally twice daily for 3 weeks and 20mg once daily for 6 months in total) for cancer patients with VTE, with a second placebo-controlled randomisation (rivaroxaban vs placebo) comparing the duration of therapy (6 vs 12 months) in residual vein thrombosis (RVT) positive patients. 70% of patients are estimated to be RVT positive after initial treatment. 530 patients are being recruited to provide reliable estimates of the primary outcome (VTE recurrence rates) to within the 95% confidence interval of 8% assuming VTE rates are 10% at six months. The secondary objectives include safety, acceptability, biomarker identification and health economics.
80 centres will participate in the trial. As of 1st June 2015, 191 patients have been recruited from 46 UK sites. select-d is amongst the first randomised trials of the new oral anticoagulants in patients with cancer, following recent recommendations from the UK National Institute of Health and Care Excellence1,2,3
The select-d trial will recruit for two years with a minimum of one year follow up. The results will support optimal treatment for this key patient group. The independent TSC and DSMC fully support this important trial.