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 |
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.
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.
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
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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...
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-632-3784
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75 Francis street
Boston, Massachusetts 02115
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...
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666 Elm Street
Buffalo, New York 14263
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...
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3500 Gaston Avenue
Dallas, Texas 75246
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...
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1150 N 35th Ave # 330
Hollywood, Florida 33021
Hollywood, Florida 33021
Phone: 954-265-4325
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701 Doctors Dr
Kinston, North Carolina 28504
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...
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22 S Greene St
Baltimore, Maryland 21201
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...
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Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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8901 Rockville Pike
Bethesda, Maryland 20889
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...
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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450 Brookline Ave
Boston, Massachusetts 2215
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...
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1200 West Harrison Stree
Chicago, Illinois 60607
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...
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Columbia, Missouri 65201
Phone: 573-814-6000
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Columbia, Missouri 65212
Phone: 573-882-7440
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1801 Inwood Rd
Dallas, Texas 75390
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...
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460 North Reading Road
Ephrata, Pennsylvania 17522
Ephrata, Pennsylvania 17522
Phone: 717-721-4838
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3401 Ludington Street
Escanaba, Michigan 49829
Escanaba, Michigan 49829
Phone: 920-884-3135
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40 V-Twin Drive
Gettysburg, Pennsylvania 17325
Gettysburg, Pennsylvania 17325
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4545 Point Fosdick Drive Northwest
Gig Harbor, Washington 98335
Gig Harbor, Washington 98335
Phone: 253-697-4875
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835 South Van Buren Street
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
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1726 Shawano Ave
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
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1726 Shawano Avenue
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
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1001 E 5th St
Greenville, North Carolina 27858
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...
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30 Prospect Ave
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-2000
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92 2nd St
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-5900
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John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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8111 South Emerson Avenue
Indianapolis, Indiana 46237
Indianapolis, Indiana 46237
Phone: 317-528-7060
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310 Sunnyview Ln
Kalispell, Montana 59901
Kalispell, Montana 59901
(406) 752-5111
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Kalispell Regional Medical Center Nestled in the beautiful Flathead Valley of Northwestern Montana, Kalispell Regional...
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3535 Southern Blvd
Kettering, Ohio 45429
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...
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4750 West Oakey Boulevard
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Phone: 702-384-0013
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6190 South Fort Apache Road
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Phone: 702-724-8787
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
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...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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844 Tuck Street
Lebanon, Pennsylvania 17042
Lebanon, Pennsylvania 17042
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800 Rose Street
Lexington, Kentucky 40536
Lexington, Kentucky 40536
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529 S Jackson St
Louisville, Kentucky 40202
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...
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530 S Jackson St
Louisville, Kentucky 40202
Louisville, Kentucky 40202
502-562-3226
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University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
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Louisville, Kentucky 40202
Phone: 502-629-3355
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