Cancer Venous Thromboembolism (VTE)

Phase 3CompletedNCT02073682

Daiichi Sankyo1,046 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,046

Conditions

Venous Thromboembolism (VTE)Deep Vein Thrombosis (DVT)Pulmonary Embolism (PE)Cancer

Interventions

EdoxabanDRUG

After the 5 day treatment with LMWH, patients receive edoxaban 60 mg once daily (QD) as 2 × 30 mg tablets (or 1 x 30 mg tablet QD for patients requiring dose adjustment) for the remainder of the treatment period.

DalteparinDRUG

Dalteparin was administered via subcutaneous injection at a dose of 200 IU/kg (maximum daily dose 18,000 IU) for 30 days, and at a dose of 150 IU/kg from Day 31 to the end of treatment.

Low molecular weight heparinDRUG

Therapeutic doses of subcutaneous LMWH were administered for at least 5 days (to patients in the edoxaban group); this 5-day period may have included the pre-randomization LMWH (if applicable). The choice of parenteral LMWH was up to the treating physician.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (9)

Unnamed facility

Brandon, Florida, United States

Unnamed facility

Jonesboro, Georgia, United States

Unnamed facility

Detroit, Michigan, United States

Unnamed facility

Norfolk, Virginia, United States

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

The primary safety endpoint was major bleeding events during the On-Treatment Study Period (defined as on-study drug or up to 3 days after the last dose of study drug).

Time frame: 12 months

Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period

Time frame: 12 months

Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period

Time frame: 12 months

Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period

Time frame: 12 months

Number of Participants With VTE-Related Death

Time frame: 12 months

Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death

Time frame: 12 months

Data from ClinicalTrials.gov

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