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.
Checked against the public recordLast updated Mar 6, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Daiichi Sankyo
- Interventions being studied
- Drug: Edoxaban; Drug: Dalteparin; Drug: Low molecular weight heparin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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;
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Study locationBrandon, Florida
- Study locationJonesboro, Georgia
- Study locationDetroit, Michigan
- Study locationNorfolk, Virginia
- Study locationLeuven, Vlaams-Brabant
- Study locationSaint-Etienne
- Study locationDebrecen, Hajdu-Bihar Megye
- Study locationVarese
- Study locationAmsterdam
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 6, 2019. Always confirm current availability with the study team.