SELECT-D is a prospective, randomised, open-label, multi-centre pilot study comparing Dalteparin versus Rivaroxaban with a second placebo-controlled randomisation comparing the duration of anticoagulation therapy (six months versus 12 months treatment) in patients with deep vein thrombosis (DVT) who are residual vein thrombosis [RVT] positive (+ve). All patients presenting with a pulmonary embolism (PE) will be invited to participate in the second randomisation.
Dalteparin (Fragmin®, Pfizer), a low molecular weight heparin, the only licensed anticoagulant in the UK for the extended treatment and prevention of recurrence of venous thromboembolism (VTE) in cancer patients
Rivaroxaban (Xarelto®, Bayer), an oral direct Factor Xa inhibitor, licensed for the treatment of DVT and the prevention of recurrence of DVT and PE in adult patients
University of Warwick (investigator-initiated study)
May 2013 – May 2015
Aged ≥ 18 with active cancer and a primary presentation of an objectively confirmed VTE – symptomatic lower extremity proximal DVT or symptomatic or incidental PE
SELECT-D has received ethics and Medicines and Healthcare products Regulatory Agency approval and aims to start recruitment in May 2013. All centres throughout the West Midlands are keen to participate. Birmingham and Warwick patients with cancer and VTE will have the opportunity to enter another trial called 'ALICAT' for the treatment of VTE. ALICAT = Anticoagulation Length In Cancer Associated Thrombosis.
For further information contact firstname.lastname@example.org or call Miss Jenny Phillips (Trial Co-ordinator) on 024 7657 3315.
The research team is:
Prof Annie Young (Principal Investigator)
Miss Asha Chauhan (Trial Administrator)
Ms Jo Grumett (Senior Project Manager)
Miss Jenny Phillips (Trial Co-ordinator)