select-d

• Research type

  Research Study

• Full title

  select-d: Anticoagulation Therapy in SELECTeD Cancer Patients at Risk of Recurrence of Venous Thromboembolism

• IRAS ID

  112845

• Contact name

  Annie Young

• Sponsor organisation

  University of Warwick

• Eudract number

  2012-005589-37

• ISRCTN Number

  n/a

• Research summary

  Venous Thromboembolism (VTE), comprising of deep vein thrombosis (DVT) and pulmonary embolism (PE), is a serious and potentially life-threatening condition, representing the second most common cause of death in cancer patients Thrombosis and cancer are linked by multiple pathophysiological mechanisms; the tumour biology and coagulation processes are closely interconnected. Furthermore, thrombotic complications can delay or interfere with anticancer therapy, precipitate or prolong hospitalisation, and consume health care resources. Optimal treatment of VTE is therefore crucial to minimising morbidity and mortality.Select-d will recruit 530 patients with active cancer. Active cancer is defined as a diagnosis of cancer (other than basal-cell orisquamous-cell carcinoma of the skin), within'six months before enrolment, any treatment for cancer within the previous six months, or recurrent or metastatic cancer.patients will be randomised initially (First Randomisation) to receive either dalteparin (Arm A) or rivaroxaban (Arm B). If there is no evidence of residual vein thrombosis (RVT) aftermsix months, treatment will cease and patients will be followed up for a minimum of one year. If aftermsix months there is evidence of RVT or PE, consent from RVT positive patients will be obtained to proceed with Second Randomisation (treatment for RVT negative patients will stop at six months). patients will be randomised to compare the duration of anticoagulation therapy (6 months vs. 12 months treatment) and will receive either rivaroxaban or placebo. All patients will also be asked to complete questionnaires at regular intervals, and to donate blood and tissue samples (sample donation is optional). A pre-planned safety analysis will be conducted after the first 200 patients have been randomised and have been on study at least 6 months. The trial will continue to 530 patients if the safety study shows no excess adverse events over and above what is expected.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  13/WM/0017

• Date of REC Opinion

  8 Feb 2013

• REC opinion

  Favourable Opinion