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Cancer Venous Thromboembolism (VTE)

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ClinicalTrials.gov Identifier: NCT02073682
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : October 24, 2018
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism (VTE) Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Cancer Drug: Edoxaban Drug: Dalteparin Drug: Low molecular weight heparin Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Experimental: Edoxaban group
After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use
 Drug: Edoxaban
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 Name: DU-176b

Drug: Low molecular weight heparin
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 Name: LMWH
Active Comparator: Dalteparin group
Participants receive Dalteparin treatment daily -solution for subcutaneous injection
 Drug: Dalteparin
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 Name: Active comparator


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073682


Locations
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United States, Florida
Brandon, Florida, United States
United States, Georgia
Jonesboro, Georgia, United States
United States, Michigan
Detroit, Michigan, United States
United States, Virginia
Norfolk, Virginia, United States
Belgium
Leuven, Vlaams-Brabant, Belgium
France
Saint-Etienne cedex 2, France
Hungary
Debrecen, Hajdu-Bihar Megye, Hungary
Italy
Varese, Italy
Netherlands
Amsterdam, Netherlands
Sponsors and Collaborators
Daiichi Sankyo
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo
  Study Documents (Full-Text)

Documents provided by Daiichi Sankyo:
Study Protocol and Statistical Analysis Plan  [PDF] January 20, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT02073682    
Other Study ID Numbers: DU176b-D-U311
2014-004708-30 ( EudraCT Number )
First Posted: February 27, 2014    Key Record Dates
Results First Posted: October 24, 2018
Last Update Posted: March 6, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Keywords provided by Daiichi Sankyo:
Active Cancer with Metastasis
Additional relevant MeSH terms:
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Pulmonary Embolism
Thrombosis
Embolism
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heparin
Heparin, Low-Molecular-Weight
 Tinzaparin
Dalteparin
Edoxaban
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors