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



Status:Recruiting
Conditions:Cancer, Cancer, Cardiology, Cardiology, Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology
Healthy:No
Age Range:21 - Any
Updated:2/23/2019
Start Date:December 2016
End Date:September 2019
Contact:Deborah Schrag, MD MPH
Email:deb_schrag@dfci.harvard.edu
Phone:617-582-8301

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
146
sites
Saint Peters, Missouri 63376
Phone: 636-916-9920
?
mi
from
Saint Peters, MO
Click here to add this to my saved trials
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Phone: 505-272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-632-3784
?
mi
from
Boston, MA
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-632-3784
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Phone: 716-845-1665
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Phone: 214-820-2468
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1150 N 35th Ave # 330
Hollywood, Florida 33021
Phone: 954-265-4325
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Phone: 252-559-2201
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
?
mi
from
Kinston, NC
Click here to add this to my saved trials
Anaconda, Montana 59711
Phone: 406-563-8606
?
mi
from
Anaconda, MT
Click here to add this to my saved trials
Asheville, North Carolina 28801
Phone: 828-213-1111
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Auburn, Washington 98002
Phone: 253-697-4875
?
mi
from
Auburn, WA
Click here to add this to my saved trials
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Phone: 410-328-7339
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
489 State St
Bangor, Maine 04401
(207) 973-7000
Phone: 207-973-7478
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
?
mi
from
Bangor, ME
Click here to add this to my saved trials
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Phone: 301-295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
801 North 29th Street
Billings, Montana 59107
406-238-2500
Phone: 406-735-7340
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
?
mi
from
Billings, MT
Click here to add this to my saved trials
90 Poly Drive
Billings, Montana 59102
Phone: 406-969-6060
?
mi
from
Billings, MT
Click here to add this to my saved trials
Boston, Massachusetts 01757
Phone: 617-632-3784
?
mi
from
Boston, MA
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-582-8301
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
915 Highland Boulevard
Bozeman, Montana 59715
Phone: 406-414-5070
?
mi
from
Bozeman, MT
Click here to add this to my saved trials
Brighton, Massachusetts 02135
Phone: 617-789-2903
?
mi
from
Brighton, MA
Click here to add this to my saved trials
Burlington, Vermont 05405
Phone: 802-847-8400
?
mi
from
Burlington, VT
Click here to add this to my saved trials
Centerville, Ohio 45459
Phone: 937-293-1622
?
mi
from
Centerville, OH
Click here to add this to my saved trials
1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Phone: 312-355-1625
Univ of Illinois A major research university in the heart of one of the world's...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60630
Phone: 773-975-1600
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chula Vista, California 91911
Phone: 619-502-3241
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Chula Vista, California 91913
Phone: 619-502-3241
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Clearwater, Florida 33756
Phone: 727-461-8526
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Clinton, North Carolina 28328
Phone: 910-592-5727
?
mi
from
Clinton, NC
Click here to add this to my saved trials
Columbia, Missouri 65201
Phone: 573-814-6000
?
mi
from
Columbia, MO
Click here to add this to my saved trials
Columbia, Missouri 65212
Phone: 573-882-7440
?
mi
from
Columbia, MO
Click here to add this to my saved trials
Columbus, Ohio 43202
Phone: 614-293-9441
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Concord, New Hampshire 03301
Phone: 603-224-2556
?
mi
from
Concord, NH
Click here to add this to my saved trials
3505 Gaston Avenue
Dallas, Texas 75246
Phone: 214-820-2687
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-5874
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
2300 North Vermilion Street
Danville, Illinois 61938
Phone: 217-431-7657
?
mi
from
Danville, IL
Click here to add this to my saved trials
Dayton, Ohio 45415
Phone: 937-293-1622
?
mi
from
Dayton, OH
Click here to add this to my saved trials
3123 Research Boulevard
Dayton, Ohio 45420
Phone: 937-775-1350
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Dayton, Ohio 45433
Phone: 937-257-9926
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Dayton, Ohio 45428
Phone: 937-268-6511
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Detroit, Michigan 48202
Phone: 313-916-9100
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Duluth, Georgia 30096
Phone: 770-623-6433
?
mi
from
Duluth, GA
Click here to add this to my saved trials
Durham, North Carolina
Phone: 919-660-7050
?
mi
from
Durham, NC
Click here to add this to my saved trials
Edgewood, Kentucky 41017
Phone: 859-301-2000
?
mi
from
Edgewood, KY
Click here to add this to my saved trials
401 North Keller Drive
Effingham, Illinois 62401
Phone: 217-347-6400
?
mi
from
Effingham, IL
Click here to add this to my saved trials
460 North Reading Road
Ephrata, Pennsylvania 17522
Phone: 717-721-4838
?
mi
from
Ephrata, PA
Click here to add this to my saved trials
3401 Ludington Street
Escanaba, Michigan 49829
Phone: 920-884-3135
?
mi
from
Escanaba, MI
Click here to add this to my saved trials
Evanston, Illinois 60201
Phone: 847-864-3278
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Fishersville, Virginia 22939
Phone: 540-332-5960
?
mi
from
Fishersville, VA
Click here to add this to my saved trials
Fort Belvoir, Virginia 22060
Phone: 571-231-3224
?
mi
from
Fort Belvoir, VA
Click here to add this to my saved trials
Fort Thomas, Kentucky 41075
Phone: 859-572-3100
?
mi
from
Fort Thomas, KY
Click here to add this to my saved trials
Franklin, Ohio 45005
Phone: 937-245-6308
?
mi
from
Franklin, OH
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
40 V-Twin Drive
Gettysburg, Pennsylvania 17325
Phone: 717-339-2638
?
mi
from
Gettysburg, PA
Click here to add this to my saved trials
4545 Point Fosdick Drive Northwest
Gig Harbor, Washington 98335
Phone: 253-697-4875
?
mi
from
Gig Harbor, WA
Click here to add this to my saved trials
?
mi
from
Glenview, IL
Click here to add this to my saved trials
Goldsboro, North Carolina 27534
Phone: 919-580-0000
?
mi
from
Goldsboro, NC
Click here to add this to my saved trials
Great Falls, Montana 59405
Phone: 406-731-8200
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
835 South Van Buren Street
Green Bay, Wisconsin 54301
Phone: 920-884-3135
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
835 S Van Buren St
Green Bay, Wisconsin 54307
Phone: 920-884-3135
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
1726 Shawano Ave
Green Bay, Wisconsin 54303
Phone: 920-884-3135
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
1726 Shawano Avenue
Green Bay, Wisconsin 54303
Phone: 920-884-3135
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Phone: 252-744-1015
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
?
mi
from
Greenville, NC
Click here to add this to my saved trials
Greenville, Ohio 45331
Phone: 937-293-1622
?
mi
from
Greenville, OH
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Phone: 551-996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
Phone: 551-996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
?
mi
from
Highland Park, IL
Click here to add this to my saved trials
Hollywood, Florida 33021
Phone: 954-265-4325
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Hollywood, Florida 33021
Phone: 954-265-4325
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Honolulu, Hawaii 96813
Phone: 808-524-6151
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Honolulu, Hawaii 96813
Phone: 808-532-0315
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Honolulu, Hawaii 96813
Phone: 808-586-2979
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Honolulu, Hawaii 96817
Phone: 808-536-4888
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Honolulu, Hawaii 96817
Phone: 808-531-8521
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Phone: 808-691-8577
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Hooksett, New Hampshire 03106
Phone: 603-622-6484
?
mi
from
Hooksett, NH
Click here to add this to my saved trials
8111 South Emerson Avenue
Indianapolis, Indiana 46237
Phone: 317-528-7060
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, North Carolina 28546
Phone: 910-353-0824
?
mi
from
Jacksonville, NC
Click here to add this to my saved trials
310 Sunnyview Ln
Kalispell, Montana 59901
(406) 752-5111
Phone: 406-752-8900
Kalispell Regional Medical Center Nestled in the beautiful Flathead Valley of Northwestern Montana, Kalispell Regional...
?
mi
from
Kalispell, MT
Click here to add this to my saved trials
Kenansville, North Carolina 28349
Phone: 910-275-1814
?
mi
from
Kenansville, NC
Click here to add this to my saved trials
Kettering, Ohio 45409
Phone: 937-293-1622
?
mi
from
Kettering, OH
Click here to add this to my saved trials
3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Phone: 937-298-3399
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
?
mi
from
Kettering, OH
Click here to add this to my saved trials
Kinston, North Carolina 28501
Phone: 252-522-7000
?
mi
from
Kinston, NC
Click here to add this to my saved trials
La Crosse, Wisconsin
Phone: 608-782-7300
?
mi
from
La Crosse, WI
Click here to add this to my saved trials
La Mesa, California 91942
Phone: 619-644-3030
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
Lakeland, Florida 33805
Phone: 863-904-1900
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
4750 West Oakey Boulevard
Las Vegas, Nevada 89102
Phone: 702-384-0013
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89128
Phone: 702-384-0013
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
3150 North Tenaya Way
Las Vegas, Nevada 89128
Phone: 702-384-0013
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
6190 South Fort Apache Road
Las Vegas, Nevada 89148
Phone: 702-724-8787
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89169
Phone: 702-384-0013
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lawrenceville, Georgia 30045
Phone: 678-312-1000
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Phone: 603-650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
844 Tuck Street
Lebanon, Pennsylvania 17042
Phone: 717-270-2238
?
mi
from
Lebanon, PA
Click here to add this to my saved trials
800 Rose Street
Lexington, Kentucky 40536
Phone: 859-257-3379
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Londonderry, New Hampshire
Phone: 603-552-9100
?
mi
from
Londonderry, NH
Click here to add this to my saved trials
529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
Phone: 502-562-4369
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Louisville, Kentucky 40202
Phone: 502-629-2000
?
mi
from
Louisville, KY
Click here to add this to my saved trials
530 S Jackson St
Louisville, Kentucky 40202
502-562-3226
Phone: 502-562-3000
University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Louisville, Kentucky 40202
Phone: 502-583-8303
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Louisville, Kentucky 40202
Phone: 502-629-3355
?
mi
from
Louisville, KY
Click here to add this to my saved trials