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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Daiichi Sankyo
- Enrollment
- 1,046
- Primary Endpoint
- Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female subjects with age ≥ 18 years or the otherwise legal lower age according to the country of residence;
- •Confirmed acute lower extremity proximal DVT or PE for which long term treatment with low molecular weight heparin (LMWH) is indicated;
- •Cancer, other than basal-cell or squamous-cell carcinoma of the skin;
- •Able to provide written informed consent.
Exclusion Criteria
- •Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
- •Treatment with therapeutic doses of an anticoagulant other than that used for pretreatment of the current (index) VTE episode prior to randomization;
- •Active bleeding or high risk for bleeding contraindicating treatment with LMWH or edoxaban;
- •Any other contraindication listed in the local labeling of dalteparin, enoxaparin, or edoxaban;
Arms & Interventions
Edoxaban group
After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use
Intervention: Edoxaban (Drug)
Edoxaban group
After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use
Intervention: Low molecular weight heparin (Drug)
Dalteparin group
Participants receive Dalteparin treatment daily -solution for subcutaneous injection
Intervention: Dalteparin (Drug)
Outcomes
Primary Outcomes
Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event
Time Frame: 12 months
Secondary Outcomes
- Number of Participants With Adjudicated Major Bleeding Events While on Treatment(12 months)
- Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period(12 months)
- Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period(12 months)
- Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death(12 months)
- Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period(12 months)
- Number of Participants With VTE-Related Death(12 months)