AzTrials
AzTrials

CancerCANVASNCT02744092

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

A study testing Rivaroxaban, Apixaban and Edoxaban in people with Cancer and Venous Thromboembolism, run by Alliance Foundation Trials, LLC. at 151 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rivaroxaban, Apixaban and Edoxaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
811 participants
Where
151 sitesUnited States
Study dates
13 Dec 2016to 22 Feb 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

151 sites in 1 country.

151 sites in 1 country

United States151 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Mission Hospital - Memorial Campus

    Asheville, North Carolina, 28801

  • MultiCare Regional Cancer Center - Auburn

    Auburn, Washington, 98001

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • Billings Clinic

    Billings, Montana, 59101

  • Montana Cancer Consortium

    Billings, Montana, 59102

  • DF/BWCC at Milford Regional Medical Center

    Boston, Massachusetts, 01757

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Bozeman Health

    Bozeman, Montana, 59715

  • St. Elizabeth's Medical Center

    Brighton, Massachusetts, 02135

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Dayton Physicians LLC, Miami Valley South

    Centerville, Ohio, 45459

  • University of Illinois

    Chicago, Illinois, 60612

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • South County Hematology

    Chula Vista, California, 91911

  • Sharp Rees-Stealy

    Chula Vista, California, 91913

  • Siteman Cancer Center - St. Peters

    City of Saint Peters, Missouri, 63376

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Southeastern Medical Oncology Center

    Clinton, North Carolina, 28328

  • Veterans Administration/Harry S Truman Memorial Hospital

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center University of Missouri Healthcare

    Columbia, Missouri, 65212

  • The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

  • New Hampshire Oncology - Hematology PA

    Concord, New Hampshire, 03301

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75204

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Carle on Vermillion

    Danville, Illinois, 61938

  • Dayton Physicians LLC, Samaritan North

    Dayton, Ohio, 45415

  • Dayton Clincial Oncology Program

    Dayton, Ohio, 45420

  • Veteran Affairs Medical Center

    Dayton, Ohio, 45428

  • Wright Patterson Medical Center

    Dayton, Ohio, 45433

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • The Center for Cancer Care-Duluth

    Duluth, Georgia, 30096

  • Duke University Health System

    Durham, North Carolina, 27710

  • Saint Elizabeth Medical Center South

    Edgewood, Kentucky, 41017

  • Carle - Effingham

    Effingham, Illinois, 62401

  • WellSpan Health Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • Green Bay Oncology, Ltd./St. Francis Hospital

    Escanaba, Michigan, 49829

  • NorthShore University HealthSystem Evanston Hospital

    Evanston, Illinois, 60201

  • Augusta Health Cancer Center

    Fishersville, Virginia, 22939

  • Fort Belvoir Community Hospital

    Fort Belvoir, Virginia, 22060

  • Saint Elizabeth Medical Center Fort Thomas

    Fort Thomas, Kentucky, 41075

  • Dayton Physicians LLC, Atrium

    Franklin, Ohio, 45005

  • Washington Hospital Healthcare System

    Fremont, California, 94538

  • Washington Hospital

    Fremont, California, 94538

  • VA Central California Fresno Medical Center

    Fresno, California, 93073

  • WellSpan Health Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • MultiCare Regional Cancer Center - Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • NorthShore University HealthSystem Glenbrook Hospital

    Glenview, Illinois, 60026

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Green Bay Oncology, Ltd./HSHS St. Vincent Hospital

    Green Bay, Wisconsin, 54301

  • HSHS St. Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology, Ltd./HSHS St. Mary's Hospital Medical Center

    Green Bay, Wisconsin, 54303

  • HSHS St. Mary's Hospital Medical Center

    Green Bay, Wisconsin, 54303

  • East Carolina University

    Greenville, North Carolina, 27834

  • Dayton Physicians, Wayne

    Greenville, Ohio, 45331

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • NorthShore University HealthSystem Highland Park Hospital

    Highland Park, Illinois, 60035

  • Breast Cancer Center at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Hawaii Cancer Care POB II

    Honolulu, Hawaii, 96813

  • Hawaii Oncology Inc POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Liliha

    Honolulu, Hawaii, 96817

  • Hawaii Oncology Inc Kuakini

    Honolulu, Hawaii, 96817

  • New Hampshire Oncology-Hematology PA

    Hooksett, New Hampshire, 03106

  • Franciscan St. Francis Health - Indianapolis

    Indianapolis, Indiana, 46237

  • Southeastern Medical Oncology Center

    Jacksonville, North Carolina, 28546

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kenansville Medical Center

    Kenansville, North Carolina, 28349

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Kinston Medical Specialists, P.A.

    Kinston, North Carolina, 28501

  • Lenoir Memorial Hospital

    Kinston, North Carolina, 28501

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Cancer Center Oncology Medical Group

    La Mesa, California, 91942

  • Hollis Cancer Center

    Lakeland, Florida, 33805

  • Nevada Cancer Specialists - Oakey

    Las Vegas, Nevada, 89102

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

  • Nevada Cancer Specialists - Tenaya

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Nevada Cancer Specialists - Fort Apache

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30046

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • WellSpan Health Sechler Family Cancer Center

    Lebanon, Pennsylvania, 17042

  • Chandler Medical Center - University of Kentucky

    Lexington, Kentucky, 40536

  • Dana-Farber/New Hampshire Oncology Hematology

    Londonderry, New Hampshire, 03053

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Norton Hospital

    Louisville, Kentucky, 40202

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

  • University of Louisville Physicians, PSC

    Louisville, Kentucky, 40202

  • University of Louisville, Division of Surgical Oncology

    Louisville, Kentucky, 40202

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Carle - Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Toledo Clinic Cancer Center - Maumee

    Maumee, Ohio, 43537

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Bon Secours Cancer Institute Medical Oncology at Memorial Regional

    Mechanicsville, Virginia, 23116

  • Woodland Cancer Care Center

    Michigan City, Indiana, 46360

  • Middlesex Hospital

    Middletown, Connecticut, 06457

  • Bon Secours Cancer Institute Medical Oncology at St. Francis

    Midlothian, Virginia, 23114

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Masonic Cancer Center University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • University of Minnesota Health: Clinics and Surgery Center

    Minneapolis, Minnesota, 55455

  • University of Minnesota Medical Center, Fairview

    Minneapolis, Minnesota, 55455

  • Community Medical Center

    Missoula, Montana, 59804

  • Franciscan St. Francis Health - Mooresville

    Mooresville, Indiana, 46158

  • SUNY Upstate Medical University

    New York, New York, 13210

  • Green Bay Oncology, Ltd./HSHS St. Clare Memorial Hospital

    Oconto Falls, Wisconsin, 54154

  • Breast Cancer Center at Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Memorial Cancer Institute at Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Kootenai Health

    Post Falls, Idaho, 83854

  • MultiCare Regional Cancer Center - Puyallup

    Puyallup, Washington, 98372

  • Onslow Medical Center

    Richlands, North Carolina, 28574

  • Reid Health

    Richmond, Indiana, 47374

  • Bon Secours Cancer Institute Medical Oncology at St. Mary's

    Richmond, Virginia, 23226

  • Medical Oncology Associates- San Diego

    San Diego, California, 92123

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Sharp Rees-Stealy

    San Diego, California, 92123

  • UCSF Medical Center - Mission Bay

    San Francisco, California, 94143

  • NorthShore University HealthSystem Skokie ACC

    Skokie, Illinois, 60076

  • The Center for Cancer Care-Snellville

    Snellville, Georgia, 30078

  • Memorial Hospital at South Bend

    South Bend, Indiana, 46601

  • South Shore Hospital

    South Weymouth, Massachusetts, 02190

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129

  • Siteman Cancer Center - West County

    St Louis, Missouri, 63141

  • The Stamford Hospital

    Stamford, Connecticut, 06904

  • Saint Joseph's Medical Center

    Stockton, California, 95204

  • Green Bay Oncology, Ltd./Door County Memorial Hospital

    Sturgeon Bay, Wisconsin, 54135

  • Multicare Institute for Research & Innovation

    Tacoma, Washington, 98405

  • MultiCare Regional Cancer Center - Tacoma

    Tacoma, Washington, 98405

  • Union Hospital

    Terre Haute, Indiana, 47804

  • Toledo Clinic Cancer Center - Toledo

    Toledo, Ohio, 43623

  • Dayton Physicians LLC, Upper valley

    Troy, Ohio, 45373

  • The Carle Foundation Hospital/Carle Cancer Center

    Urbana, Illinois, 61801

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

  • WellSpan Health York Cancer Center

    York, Pennsylvania, 17403

Other trials in United States

About this study

Official title: Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS 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 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.

Read the 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 811 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.

Being tested
Rivaroxaban, Apixaban, Edoxaban, Dabigatran, Warfarin
Keywords
Rivaroxaban (Xarelto), Apixaban (Eliquis), Edoxaban (Savaysa), Dabigatran (Pradaxa), Warfarin (Coumadin), Low molecular weight heparin (LMWH)
Medical subject headings
Neoplasms, Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivaroxabanDrug

    Also called Xarelto

    Anticoagulation therapy.

  • ApixabanDrug

    Also called Eliquis

    Anticoagulation therapy.

  • EdoxabanDrug

    Also called Savaysa

    Anticoagulation therapy.

  • DabigatranDrug

    Also called Pradaxa

    Anticoagulation therapy.

  • WarfarinDrug

    Also called Coumadin

    Anticoagulation therapy.

  • DalteparinDrug

    Also called Fragmin

    Anticoagulation therapy.

  • EnoxaparinDrug

    Also called Lovenox

    Anticoagulation therapy.

  • FondaparinuxDrug

    Also called Arixtra

    Anticoagulation therapy.

Study groups in NCT02744092
Study groupRoleWhat they receive
Randomized Arm 1 (DOACs)Active comparatorRandomized 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.
Receives: Drug: Rivaroxaban; Drug: Apixaban; Drug: Edoxaban; Drug: Dabigatran
Randomized Arm 2 (LMWH)Active comparatorRandomized 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.
Receives: Drug: Warfarin; Drug: Dalteparin; Drug: Enoxaparin; Drug: Fondaparinux
Preference Cohort 1 (DOACs)Active comparatorIf 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).
Receives: Drug: Rivaroxaban; Drug: Apixaban; Drug: Edoxaban; Drug: Dabigatran
Preference Cohort 2 (LMWH)Active comparatorIf 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 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.
Receives: Drug: Warfarin; Drug: Dalteparin; Drug: Enoxaparin; Drug: Fondaparinux

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative Non-Fatal VTE Recurrence at 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. Only VTEs that were nonfatal were considered because of the challenges of attributing cause of death in cancer patients to tumor progression vs. VTE.

    Measured: 6 months

Secondary outcomes (10)

  1. Cumulative Rates of Major Bleeding

    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. d. Major bleeding was defined as Grade >=3 on the Common Terminology Criteria for Adverse Events from the National Cancer Institute (NCI CTCAE) criteria version 5.0 (i.e., severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living).

    Measured: 6 months

  2. Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire

    Change in physical health at 3 months. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The presented scores in this results section indicate the change (difference) in mean scores between the baseline and 3-month follow-up assessment.

    Measured: 3 months

  3. Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

    To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden).

    Measured: 3 months

  4. Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)

    To compare the impact of DOAC vs. LMWH/warfarin therapy on mortality in cancer patients with VTE based on survival at 6 months. Mortality was reported by participants' surrogates (via study-specific questionnaire) or clinicians (via study-specific case report form)

    Measured: 6 months

  5. Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire

    Change in physical health at 6 months. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The presented scores in this results section indicate the change (difference) in mean scores between the baseline and 6-month follow-up assessment.

    Measured: 6 months

  6. Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

    To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden).

    Measured: 6 months

  7. Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

    To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits).

    Measured: 3-months

  8. Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

    To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits).

    Measured: 6-months

  9. Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 3-months

    Change in mental health at 3 months from baseline. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The scores indicate change in score from baseline.

    Measured: 3-months

  10. Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 6-months

    Change in mental health at 6 months from baseline. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The scores indicate change in score from baseline.

    Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2016 (estimated)
  2. Study start13 Dec 2016
  3. Primary completion31 Oct 2020
  4. Study completion22 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
811 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02744092
Sponsor's protocol ID
AFT-28
Other IDs
CER-1503-29805
Acronym
CANVAS
Status last verified
Feb 2023
First submitted
11 Apr 2016
Last updated
3 Oct 2023
Data monitoring committee
Yes
Individual data sharing
Yes: 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 the study chairs at the Dana-Farber Cancer Institute. Prior to the release of datasets, DFCI will ensure 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 DFCI.

Publications

  • Schrag D, Uno H, Rosovsky R, Rutherford C, Sanfilippo K, Villano JL, Drescher M, Jayaram N, Holmes C, Feldman L, Zattra O, Farrar-Muir H, Cronin C, Basch E, Weiss A, Connors JM; CANVAS Investigators. Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin and Recurrent VTE in Patients With Cancer: A Randomized Clinical Trial. JAMA. 2023 Jun 13;329(22):1924-1933. doi: 10.1001/jama.2023.7843.

    PubMed 37266947

  • Riaz IB, Fuentes HE, Naqvi SAA, He H, Sipra QR, Tafur AJ, Padranos L, Wysokinski WE, Marshall AL, Vandvik PO, Montori V, Bryce AH, Liu H, Badgett RG, Murad MH, McBane RD 2nd. Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis. Mayo Clin Proc. 2022 Feb;97(2):308-324. doi: 10.1016/j.mayocp.2020.10.041. Epub 2021 Jun 22.

    PubMed 34172290

Questions about this trial

What is this clinical trial studying?

A study testing Rivaroxaban, Apixaban and Edoxaban in people with Cancer and Venous Thromboembolism, run by Alliance Foundation Trials, LLC. at 151 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Non-Fatal VTE Recurrence at 6 Months (%) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02744092, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.

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