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Trial record 26 of 56 for:    "Lung Disease" | "Dalteparin"

Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer (CANVAS)

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ClinicalTrials.gov Identifier: NCT02744092
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Alliance Foundation Trials, LLC.

Tracking Information
First Submitted Date  ICMJE April 11, 2016
First Posted Date  ICMJE April 20, 2016
Last Update Posted Date November 13, 2019
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
Cumulative VTE recurrence reported by participants (via study-specific questionnaire) or clinicians (via study-specific case report form) [ Time Frame: 6 months ]
To compare the effectiveness of anticoagulation with a DOAC (intervention) with LMWH/warfarin (comparator) for preventing VTE recurrence in patients with cancer based on cumulative VTE recurrence reported by patients or clinicians at 6 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02744092 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • Cumulative rates of major bleeding reported by participants (via study-specific questionnaire) or clinicians (via study-specific case report form) [ Time Frame: 6 months ]
    To compare the harms of DOAC vs. LMWH/warfarin therapy for cancer patients with VTE based on the cumulative rate of major bleeding at 6 months.
  • Health related quality of life reported by participants via the Optum SF-12v2 Health Survey questionnaire [ Time Frame: 3 and 6 months ]
    To compare the impact of DOAC vs. LMWH/warfarin therapy on the health related quality of life (HRQOL) for cancer patients with VTE at 3 and 6 months.
  • Burden of anticoagulation therapy reported by participants via the Anti-Clot Treatment Scale (ACTS) questionnaire [ Time Frame: 3 and 6 months ]
    To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 and 6 months.
  • Mortality reported by participants' surrogates (via study-specific questionnaire) or clinicians (via study-specific case report form) [ Time Frame: 6 months ]
    To compare the impact of DOAC vs. LMWH/warfarin therapy on mortality in cancer patients with VTE based on survival at 6 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer
Official Title  ICMJE Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
Brief Summary The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The intervention strategy is Direct Oral AntiCoagulants (DOAC) therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is low molecular weight heparin (LMWH) alone or with warfarin. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.
Detailed Description

Venous blood clots affect nearly a million Americans each year. Venous clots in the legs are called deep venous thrombosis (DVT) and are dangerous because they travel to the lungs where they cause blockages known as pulmonary emboli (PE). DVT and PE are called venous thromboemboli (VTE). Cancer is a risk factor with nearly 200,000 VTEs in cancer patients each year. The purpose of VTE treatment is to prevent the initial clot from spreading and to prevent new clots from forming. This is accomplished by thinning the blood, or anticoagulation. Without anticoagulation, VTEs recur and are often fatal.

Recently, the FDA has approved 4 new Direct Oral AntiCoagulants (DOACs) for preventing VTE recurrence. Few cancer patients were included in the efficacy trials, and practice guidelines fall silent on whether switching to DOAC therapy is advisable. To fill this knowledge gap, the Alliance Foundation Trials LLC, a research network of academic and community practices across the US, is conducting a pragmatic randomized effectiveness trial.

The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The investigators will conduct a trial of 940 cancer patients followed for 6 months. The intervention strategy is DOAC therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is LMWH alone or with warfarin. Within each arm, patients can choose the agent they prefer based on side effects, drug interactions, and practical issues such as co-pays. The trial compares these two strategies in terms of treatment: 1) benefits based on VTE recurrence; 2) harms based on bleeding rates; 3) burdens based on patients' reports of their experiences; and 4) mortality rates.

The investigators hypothesize that the benefits, harms and burdens of DOAC treatment will be non-inferior to, or better than, usual care with LMWH/ warfarin among cancer patients. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Venous Thromboembolism
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Blood Clot
Intervention  ICMJE
  • Drug: Rivaroxaban
    Anticoagulation therapy.
    Other Name: Xarelto
  • Drug: Apixaban
    Anticoagulation therapy.
    Other Name: Eliquis
  • Drug: Edoxaban
    Anticoagulation therapy.
    Other Name: Savaysa
  • Drug: Dabigatran
    Anticoagulation therapy.
    Other Name: Pradaxa
  • Drug: Warfarin
    Anticoagulation therapy.
    Other Name: Coumadin
  • Drug: Dalteparin
    Anticoagulation therapy.
    Other Name: Fragmin
  • Drug: Enoxaparin
    Anticoagulation therapy.
    Other Name: Lovenox
  • Drug: Fondaparinux
    Anticoagulation therapy.
    Other Name: Arixtra
Study Arms  ICMJE
  • Experimental: Randomized Arm 1
    Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.
    Interventions:
    • Drug: Rivaroxaban
    • Drug: Apixaban
    • Drug: Edoxaban
    • Drug: Dabigatran
  • Active Comparator: Randomized Arm 2
    Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.
    Interventions:
    • Drug: Warfarin
    • Drug: Dalteparin
    • Drug: Enoxaparin
    • Drug: Fondaparinux
  • Experimental: Preference Cohort

    If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).

    Preference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).

    Preference cohort: Non-randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin.

    Interventions:
    • Drug: Rivaroxaban
    • Drug: Apixaban
    • Drug: Edoxaban
    • Drug: Dabigatran
    • Drug: Warfarin
    • Drug: Dalteparin
    • Drug: Enoxaparin
    • Drug: Fondaparinux
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)
940
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of advanced solid tumor cancer, lymphoma, or myeloma (no time restrictions or limitations) -OR- diagnosis of early stage solid tumor cancer, lymphoma, or myeloma <= 12 months prior to study enrollment
  • Diagnosis of VTE <= 30 days prior to study enrollment for which potential benefits of anticoagulation therapy to prevent recurrence of VTE are felt by the treating physician to exceed the potential harms

    • Any anticoagulation drug/strategy may be used to treat the index VTE; protocol treatment will begin <= 30days after the index VTE diagnosis date
  • Treating physician intends to put participant on anticoagulation therapy for at least three months.
  • Age >= 18 years
  • Platelet count is >= 50,000/mm^3 (<= 7 days prior to enrollment)
  • CrCl (Creatinine Clearance) is >= 15 ml/min (<= 7 days prior to enrollment)

Exclusion Criteria:

  • Diagnosis of acute leukemia
  • Has ever received or is scheduled to receive an Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)

    • Patients who have ever received an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) ARE eligible.
    • Patients who are scheduled to receive an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) are NOT eligible
  • Ongoing, clinically significant bleeding (CTCAE grade 3 or 4)
  • Ongoing therapy with a P-gp inhibitor (e.g., nelfinavir, indinavir, or saquinavir-protease inhibitors for HIV) as these drugs interact with the factor Xa inhibitors
  • Therapy with any azole antifungals (e.g., itraconazole, ketaconazole, voriconazole) at the time of enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Deborah Schrag, MD MPH 617-582-8301 deb_schrag@dfci.harvard.edu
Contact: Jean Connors, MD 617-525-9337 jconnors@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02744092
Other Study ID Numbers  ICMJE AFT-28
CER-1503-29805 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Individual-level de-identified datasets will be made available to investigators working under an institution with a Federal Wide Assurance (FWA) who formally submit a request to Alliance Foundation Trials LLC (AFT). Prior to the release of datasets, AFT ensures certain requirements, e.g., IRB approval and data use agreement, are in place. These datasets will be available within 6 months of publication of the manuscript and following a formal request by an investigator to and approval from AFT.
Responsible Party Alliance Foundation Trials, LLC.
Study Sponsor  ICMJE Alliance Foundation Trials, LLC.
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Study Chair: Deborah Schrag, MD MPH Alliance Foundation Trials, LLC.
Study Chair: Jean Connors, MD Alliance Foundation Trials, LLC.
PRS Account Alliance Foundation Trials, LLC.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP