SELECT-D is an integrated, primary and secondary health care sector-led, Phase III, 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 indefinite treatment) in residual vein thrombosis [RVT] positive (+ve) patients. This is a UK-wide trial, directed by Warwick Medical School, University Hospitals Coventry and Warwickshire, West Midlands South Comprehensive Local Research Network, Thames Valley and West Midlands South Primary Care Research Networks.
Patients with any malignancy (solid and haematological) treated with palliative and adjuvant intent, who have a primary presentation of an objectively confirmed symptomatic venous thromboembolism, that is a symptomatic deep vein thrombosis or a symptomatic pulmonary embolus, are eligible.
The aim of the trial is to assess the cumulative venous thromboembolism recurrence rates in 530 SELECTeD cancer patients at risk of recurrence of venous thromboembolism treated with Rivaroxaban or Dalteparin.
The main objectives are to:
- Ensure the safety of the patients (major bleeding)
- Assess acceptability and compliance to randomisation and allocated treatment
- Assess six months and 12 months treatment with Rivaroxaban in patients with evidence of RVT, following initial therapy
The trial is made possible through an educational grant from Bayer plc.
The research team is:
Prof Annie Young (Joint Principal Investigator)
Mrs Andrea Marshall (Joint Principal Investigator)
Ms Joanne Grumett (Project Officer)