Project Title

Cancer Venous Thromboembolism (VTE).

Official Title

A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer.

Project Summary

The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.

Blood Disorder

  • Venous Thromboembolism
  • Deep Vein Thrombosis 
  • Pulmonary Embolism
  • Cancer

Patient Recruitment Details

Patient recruitment status: Closed

Number of Patients (globally)

1046 participants.

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