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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02744092
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Alliance Foundation Trials, LLC.

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.

Condition or disease Intervention/treatment Phase
Cancer Venous Thromboembolism Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Blood Clot Drug: Rivaroxaban Drug: Apixaban Drug: Edoxaban Drug: Dabigatran Drug: Warfarin Drug: Dalteparin Drug: Enoxaparin Drug: Fondaparinux Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 940 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
Study Start Date : December 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
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.
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

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.
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

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.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 >= 21 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

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): NCT02744092


Contacts
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Contact: Deborah Schrag, MD MPH 617-582-8301 deb_schrag@dfci.harvard.edu
Contact: Jean Connors, MD 617-525-9337 jconnors@partners.org

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Locations
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United States, California
South County Hematology Recruiting
Chula Vista, California, United States, 91911
Contact: Kenneth Johnson, MD    619-502-3241      
Sharp Rees-Stealy Recruiting
Chula Vista, California, United States, 91913
Contact: Kenneth Johnson, MD    619-502-3241      
VA Central California Fresno Medical Center Recruiting
Fresno, California, United States, 93073
Cancer Center Oncology Medical Group Recruiting
La Mesa, California, United States, 91942
Contact: Kenneth Johnson, MD    619-644-3030      
Medical Oncology Associates- San Diego Recruiting
San Diego, California, United States, 92123
Contact: Kenneth Johnson, MD    858-939-5060      
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Kenneth Johnson, MD    858-939-3400      
Sharp Rees-Stealy Recruiting
San Diego, California, United States, 92123
Contact: Kenneth Johnson, MD    858-939-6612      
UCSF Medical Center - Mission Bay Recruiting
San Francisco, California, United States, 94143
Contact: Andrew Leavitt, MD    415-353-7463      
Saint Joseph's Medical Center Recruiting
Stockton, California, United States, 95204
Contact: Neelesh Bangalore, MD    209-943-2000      
United States, Connecticut
Middlesex Hospital Recruiting
Middletown, Connecticut, United States, 06457
Contact: Suasnna Hong, MD    860-358-2070      
The Stamford Hospital Recruiting
Stamford, Connecticut, United States, 06904
Contact: K.M. Steve Lo, MD    203-276-8450      
United States, Florida
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Contact: Ben Yan, MD    727-461-8526      
Breast Cancer Center at Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Anna Abraham, MD    954-265-4325      
Memorial Cancer Institute at Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Anna Abraham, MD    954-265-4325      
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Anna Abraham, MD    954-265-4325      
Hollis Cancer Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Madhavi Venigalla, MD    863-904-1900      
Breast Cancer Center at Memorial Hospital West Recruiting
Pembroke Pines, Florida, United States, 33028
Contact: Anna Abraham, MD    954-265-4325      
Memorial Cancer Institute at Memorial Hospital West Recruiting
Pembroke Pines, Florida, United States, 33028
Contact: Anna Abraham, MD    954-265-4325      
Memorial Hospital West Recruiting
Pembroke Pines, Florida, United States, 33028
Contact: Anna Abraham, MD    954-265-4325      
United States, Georgia
The Center for Cancer Care-Duluth Recruiting
Duluth, Georgia, United States, 30096
Contact: Aldemar Montero, MD    770-623-6433      
Gwinnett Medical Center Recruiting
Lawrenceville, Georgia, United States, 30046
Contact: Aldemar Montero, MD    678-312-1000      
The Center for Cancer Care-Snellville Recruiting
Snellville, Georgia, United States, 30078
Contact: Aldemar Montero, MD    770-979-2828      
United States, Hawaii
Hawaii Cancer Care POB II Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Kenneth Sumida, MD    808-524-6151      
Hawaii Oncology Inc POB I Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Kenneth Sumida, MD    808-532-0315      
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Kenneth Sumida, MD    808-691-8577      
University of Hawaii Cancer Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Kenneth Sumida, MD    808-586-2979      
Hawaii Cancer Care Liliha Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Kenneth Sumida, MD    808-536-4888      
Hawaii Oncology Inc Kuakini Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Kenneth Sumida, MD    808-531-8521      
United States, Idaho
Kootenai Health Recruiting
Post Falls, Idaho, United States, 83854
Contact: Benjamin Marchello, MD    208-625-4700      
United States, Illinois
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Lawrence Feldman, MD    312-355-1625      
Advocate Illinois Masonic Medical Center Recruiting
Chicago, Illinois, United States, 60657
Contact: Mebea Aklilu, MD    773-975-1600      
Carle on Vermillion Recruiting
Danville, Illinois, United States, 61938
Contact: Yujie Zhao, MD    217-431-7657      
Carle - Effingham Recruiting
Effingham, Illinois, United States, 62401
Contact: Yujie Zhao, MD    217-347-6400      
NorthShore University HealthSystem Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Alfonso Tafur, MD    847-864-3278      
NorthShore University HealthSystem Glenbrook Hospital Recruiting
Glenview, Illinois, United States, 60026
Contact: Alfonso Tafur, MD         
NorthShore University HealthSystem Highland Park Hospital Recruiting
Highland Park, Illinois, United States, 60035
Contact: Alfonso Tafur, MD         
Carle - Mattoon/Charleston Recruiting
Mattoon, Illinois, United States, 61938
Contact: Yujie Zhao, MD    217-258-3657      
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Andrea Dean, MD    708-216-9000      
NorthShore University HealthSystem Skokie ACC Recruiting
Skokie, Illinois, United States, 60076
Contact: Alfonso Tafur, MD    847-864-3278      
The Carle Foundation Hospital/Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Yujie Zhao, MD    217-383-3010      
United States, Indiana
Franciscan St. Francis Health - Indianapolis Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Meghana Raghavendra, MD    317-528-7060      
Woodland Cancer Care Center Recruiting
Michigan City, Indiana, United States, 46360
Contact: Meghana Raghavendra, MD    219-861-5850      
Franciscan St. Francis Health - Mooresville Recruiting
Mooresville, Indiana, United States, 46158
Contact: Meghana Raghavendra, MD    317-834-3603      
Reid Health Recruiting
Richmond, Indiana, United States, 47374
Contact: Heather Riggs, MD    765-983-3000      
Memorial Hospital at South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Thomas Reid, MD    574-647-1000      
Union Hospital Recruiting
Terre Haute, Indiana, United States, 47804
Contact: Meghana Raghavendra, MD    812-238-7504      
United States, Kentucky
Saint Elizabeth Medical Center South Recruiting
Edgewood, Kentucky, United States, 41017
Contact: Daniel Flora, MD    859-301-2000      
Saint Elizabeth Medical Center Fort Thomas Recruiting
Fort Thomas, Kentucky, United States, 41075
Contact: Daniel Flora, MD    859-572-3100      
Chandler Medical Center - University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: John Villano, MD    859-257-3379      
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Robert Martin, MD    502-562-4369      
Norton Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Robert Martin, MD    502-629-2000      
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Robert Martin, MD    502-562-3000      
University of Louisville Physicians, PSC Recruiting
Louisville, Kentucky, United States, 40202
Contact: Robert Martin, MD    502-583-8303      
University of Louisville, Division of Surgical Oncology Recruiting
Louisville, Kentucky, United States, 40202
Contact: Robert Martin, MD    502-629-3355      
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Thomas Openshaw, MD    207-973-7478      
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Paula Rosenblatt, MD    410-328-7339      
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Charlotte Marcus, MD    301-295-4000      
United States, Massachusetts
DF/BWCC at Milford Regional Medical Center Recruiting
Boston, Massachusetts, United States, 01757
Contact: Michael Constantine, MD    617-632-3784      
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rachel Rosovsky, MD    617-632-3784      
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jean Connors, MD    617-632-3784      
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Deborah Schrag, MD    617-582-8301      
St. Elizabeth's Medical Center Recruiting
Brighton, Massachusetts, United States, 02135
Contact: Christopher Lathan, MD    617-789-2903      
Lowell General Hospital Recruiting
Lowell, Massachusetts, United States, 01854
Contact: Richard Zuniga, MD    978-937-6800      
South Shore Hospital Recruiting
South Weymouth, Massachusetts, United States, 02190
Contact: Meredith Faggen, MD    781-624-8000      
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Vinay Shah, MD    313-916-9100    vshah2@hfhs.org   
Green Bay Oncology, Ltd./St. Francis Hospital Recruiting
Escanaba, Michigan, United States, 49829
Contact: Anthony Jaslowski, MD    920-884-3135      
United States, Missouri
Veterans Administration/Harry S Truman Memorial Hospital Recruiting
Columbia, Missouri, United States, 65201
Contact: Clint Kingsley, MD    573-814-6000      
Ellis Fischel Cancer Center University of Missouri Healthcare Recruiting
Columbia, Missouri, United States, 65212
Contact: Clint Kingsley, MD    573-882-7440      
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kristen Sanfilippo, MD    800-600-3606      
Siteman Cancer Center - South County Recruiting
Saint Louis, Missouri, United States, 63129
Contact: Kristen Sanfilippo, MD    314-286-2500      
Siteman Cancer Center - West County Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Kristen Sanfilippo, MD    800-600-3606      
Siteman Cancer Center - St. Peters Recruiting
Saint Peters, Missouri, United States, 63376
Contact: Kristen Sanfilippo, MD    636-916-9920      
United States, Montana
Community Hospital of Anaconda Recruiting
Anaconda, Montana, United States, 59711
Contact: Benjamin Marchello, MD    406-563-8606      
Billings Clinic Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin Marchello, MD    406-735-7340      
Montana Cancer Consortium Recruiting
Billings, Montana, United States, 59102
Contact: Benjamin Marchello, MD    406-969-6060      
Bozeman Health Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin Marchello, MD    406-414-5070      
Benefis Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin Marchello, MD    406-731-8200      
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin Marchello, MD    406-752-8900      
Community Medical Center Recruiting
Missoula, Montana, United States, 59804
Contact: Benjamin Marchello, MD    406-327-3911      
United States, Nevada
Nevada Cancer Specialists - Oakey Recruiting
Las Vegas, Nevada, United States, 89102
Contact: John Ellerton, MD    702-384-0013      
Ann M Wierman MD LTD Recruiting
Las Vegas, Nevada, United States, 89128
Contact: John Ellerton, MD    702-384-0013      
Nevada Cancer Specialists - Tenaya Recruiting
Las Vegas, Nevada, United States, 89128
Contact: John Ellerton, MD    702-384-0013      
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89148
Contact: John Ellerton, MD    702-384-0013      
Nevada Cancer Specialists - Fort Apache Recruiting
Las Vegas, Nevada, United States, 89148
Contact: John Ellerton, MD    702-724-8787      
Comprehensive Cancer Centers of Nevada - Central Valley Recruiting
Las Vegas, Nevada, United States, 89169
Contact: John Ellerton, MD    702-384-0013      
United States, New Hampshire
New Hampshire Oncology - Hematology PA Recruiting
Concord, New Hampshire, United States, 03301
Contact: Douglas Weckstein, MD    603-224-2556      
New Hampshire Oncology-Hematology PA Recruiting
Hooksett, New Hampshire, United States, 03106
Contact: Douglas Weckstein, MD    603-622-6484      
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Monic Roengvoraphoj, MD    603-650-5000      
Dana-Farber/New Hampshire Oncology Hematology Recruiting
Londonderry, New Hampshire, United States, 03053
Contact: Fred Briccetti, MD    603-552-9100      
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Samuel Goldlust, MD    551-996-2000      
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Samuel Goldlust, MD    551-996-5900      
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Jessica Belmonte, MD    505-272-4946      
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Ellis Levine, MD    716-845-1665      
SUNY Upstate Medical University Recruiting
New York, New York, United States, 13210
Contact: Muhammad Naqvi, MD    315-464-4353      
United States, North Carolina
Mission Hospital - Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Christopher Chay, MD    828-213-1111      
Southeastern Medical Oncology Center Recruiting
Clinton, North Carolina, United States, 28328
Contact: James Atkins, MD    910-592-5727      
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: Ara Metjian, MD    919-660-7050      
Southeastern Medical Oncology Center Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James Atkins, MD    919-580-0000      
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Darla Liles, MD    252-744-1015      
Southeastern Medical Oncology Center Recruiting
Jacksonville, North Carolina, United States, 28546
Contact: James Atkins, MD    910-353-0824      
Kenansville Medical Center Recruiting
Kenansville, North Carolina, United States, 28349
Contact: Peter Watson, MD    910-275-1814      
Kinston Medical Specialists, P.A. Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter Watson, MD    252-559-2201      
Lenoir Memorial Hospital Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter Watson, MD    252-522-7000      
Onslow Medical Center Recruiting
Richlands, North Carolina, United States, 28574
Contact: Peter Watson, MD    910-324-7328      
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Michael Goodman, MD    336-713-5440      
United States, Ohio
Dayton Physicians LLC, Miami Valley South Recruiting
Centerville, Ohio, United States, 45459
Contact: Howard Gross, MD    937-293-1622      
The James Cancer Hospital and Solove Research Institute Recruiting
Columbus, Ohio, United States, 43210
Contact: Tzu-Fei Wang, MD    614-293-9441      
Dayton Physicians LLC, Samaritan North Recruiting
Dayton, Ohio, United States, 45415
Contact: Howard Gross, MD    937-293-1622      
Dayton Clincial Oncology Program Recruiting
Dayton, Ohio, United States, 45420
Contact: Howard Gross, MD    937-775-1350      
Veteran Affairs Medical Center Recruiting
Dayton, Ohio, United States, 45428
Contact: Albert S Malcolm, MD    937-268-6511      
Wright Patterson Medical Center Recruiting
Dayton, Ohio, United States, 45433
Contact: Roger Wood, MD    937-257-9926      
Dayton Physicians LLC, Atrium Recruiting
Franklin, Ohio, United States, 45005
Contact: Howard Gross, MD    937-245-6308      
Dayton Physicians, Wayne Recruiting
Greenville, Ohio, United States, 45331
Contact: Howard Gross, MD    937-293-1622      
Greater Dayton Cancer Center Recruiting
Kettering, Ohio, United States, 45409
Contact: Howard Gross, MD    937-293-1622      
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Contact: Howard Gross, MD    937-298-3399 ext 57556      
Toledo Clinic Cancer Center - Maumee Recruiting
Maumee, Ohio, United States, 43537
Contact: Rex Mowat, MD    419-479-5605      
Toledo Clinic Cancer Center - Toledo Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex Mowat, MD    419-479-5605      
Dayton Physicians LLC, Upper valley Recruiting
Troy, Ohio, United States, 45373
Contact: Howard Gross, MD    937-293-1622      
United States, Pennsylvania
WellSpan Health Ephrata Cancer Center Recruiting
Ephrata, Pennsylvania, United States, 17522
Contact: Dan Sotirescu, MD    717-721-4838      
WellSpan Health Adams Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Dan Sotirescu, MD    717-339-2638      
WellSpan Health Sechler Family Cancer Center Recruiting
Lebanon, Pennsylvania, United States, 17042
Contact: Dan Sotirescu, MD    717-270-2238      
Western Pennsylvania Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Robert Kaplan, MD    412-578-4492      
WellSpan Health York Cancer Center Recruiting
York, Pennsylvania, United States, 17403
Contact: Dan Sotirescu, MD    717-741-8303      
United States, Texas
Baylor Scott & White Research Institute Recruiting
Dallas, Texas, United States, 75204
Contact: James Fleshman, MD    214-820-2687      
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: James Fleshman, MD    214-820-2468      
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Cynthia Rutherford, MD    214-648-5874      
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Chris Holmes, MD    802-847-8400      
United States, Virginia
Augusta Health Cancer Center Recruiting
Fishersville, Virginia, United States, 22939
Contact: Kelvin Raybon, MD    540-332-5960      
Fort Belvoir Community Hospital Recruiting
Fort Belvoir, Virginia, United States, 22060
Contact: Charlotte Marcus, MD    571-231-3224      
Bon Secours Cancer Institute Medical Oncology at Memorial Regional Recruiting
Mechanicsville, Virginia, United States, 23116
Contact: William Irvin, MD    804-594-3131      
Bon Secours Cancer Institute Medical Oncology at St. Francis Recruiting
Midlothian, Virginia, United States, 23114
Contact: William Irvin, MD    804-893-8717      
Bon Secours Cancer Institute Medical Oncology at St. Mary's Recruiting
Richmond, Virginia, United States, 23226
Contact: William Irvin, MD    804-893-8717      
United States, Washington
MultiCare Regional Cancer Center - Auburn Recruiting
Auburn, Washington, United States, 98001
Contact: John Keech, MD    253-697-4875      
MultiCare Regional Cancer Center - Gig Harbor Medical Park Recruiting
Gig Harbor, Washington, United States, 98335
Contact: John Keech, MD    253-697-4875      
MultiCare Regional Cancer Center - Puyallup Recruiting
Puyallup, Washington, United States, 98372
Contact: John Keech, MD    253-697-4875      
Multicare Institute for Research & Innovation Recruiting
Tacoma, Washington, United States, 98405
Contact: John Keech, MD    253-697-4875      
MultiCare Regional Cancer Center - Tacoma Recruiting
Tacoma, Washington, United States, 98405
Contact: John Keech, MD    253-697-4875      
United States, Wisconsin
Green Bay Oncology, Ltd./HSHS St. Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Anthony Jaslowski, MD    920-884-3135      
HSHS St. Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Anthony Jaslowski, MD    920-884-3135      
Green Bay Oncology, Ltd./HSHS St. Mary's Hospital Medical Center Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony Jaslowski, MD    920-884-3135      
HSHS St. Mary's Hospital Medical Center Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony Jaslowski, MD    920-884-3135      
Gundersen Lutheran Medical Center Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Lori Rosenstein, MD    608-782-7300      
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Eliot Williams, MD    608-263-2944      
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Lisa Baumann Kreuziger, MD    414-222-0984      
Green Bay Oncology, Ltd./HSHS St. Clare Memorial Hospital Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: Anthony Jaslowski, MD    920-884-3135      
Green Bay Oncology, Ltd./Door County Memorial Hospital Recruiting
Sturgeon Bay, Wisconsin, United States, 54135
Contact: Anthony Jaslowski, MD    920-884-3135      
Sponsors and Collaborators
Alliance Foundation Trials, LLC.
Patient-Centered Outcomes Research Institute
Investigators
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Study Chair: Deborah Schrag, MD MPH Alliance Foundation Trials, LLC.
Study Chair: Jean Connors, MD Alliance Foundation Trials, LLC.

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: AFT-28
Email the study team at CANVAS@AllianceFoundationTrials.org.

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Responsible Party: Alliance Foundation Trials, LLC.
ClinicalTrials.gov Identifier: NCT02744092     History of Changes
Other Study ID Numbers: AFT-28
CER-1503-29805 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI) )
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by Alliance Foundation Trials, LLC.:
Rivaroxaban (Xarelto)
Apixaban (Eliquis)
Edoxaban (Savaysa)
Dabigatran (Pradaxa)
Warfarin (Coumadin)
Low molecular weight heparin (LMWH)

Additional relevant MeSH terms:
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Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heparin
Warfarin
Rivaroxaban
Dabigatran
Apixaban
Heparin, Low-Molecular-Weight
Dalteparin
Edoxaban
Fondaparinux
PENTA
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors