Cancer Venous Thromboembolism (VTE)
Cancer Venous Thromboembolism (VTE)
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.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 1046 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date: July 16, 2015
Actual Primary Completion Date: September 15, 2017
Actual Study Completion Date: September 15, 2017
Arms:
- Experimental: Edoxaban group
- Active Comparator: Dalteparin group
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 1046 |
| Study start date | 16 July 2015 |
| Actual study completion date | 15 September 2017 |