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Completed

NCT Number: NCT02073682

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.

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Key information

Conditions

Venous Thromboembolism (VTE) Cancer Cardiovascular Diseases Deep Vein Thrombosis (DVT) Embolism Embolism and Thrombosis Lung Diseases Neoplasms Pulmonary Embolism Pulmonary Embolism (PE) Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Leuven, Vlaams-Brabant, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Edoxaban

Drug

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.

Other names: DU-176b

Dalteparin

Drug

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.

Other names: Active comparator

Low molecular weight heparin

Drug

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.

Other names: LMWH

Primary outcomes

  1. Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event

    Time frame: 12 months

Secondary outcomes

  1. Number of Participants With Adjudicated Major Bleeding Events While on Treatment

    Time frame: 12 months

    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).

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

  5. Number of Participants With VTE-Related Death

    Time frame: 12 months

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 27, 2014
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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