- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02744092
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer (CANVAS)
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Chula Vista, California, United States, 91911
- South County Hematology
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Chula Vista, California, United States, 91913
- Sharp Rees-Stealy
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Fremont, California, United States, 94538
- Washington Hospital
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Fremont, California, United States, 94538
- Washington Hospital Healthcare System
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Fresno, California, United States, 93073
- VA Central California Fresno Medical Center
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La Mesa, California, United States, 91942
- Cancer Center Oncology Medical Group
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San Diego, California, United States, 92123
- Sharp Rees-Stealy
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San Diego, California, United States, 92123
- Sharp Memorial Hospital
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San Diego, California, United States, 92123
- Medical Oncology Associates- San Diego
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San Francisco, California, United States, 94143
- UCSF Medical Center - Mission Bay
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Stockton, California, United States, 95204
- Saint Joseph's Medical Center
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Connecticut
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Middletown, Connecticut, United States, 06457
- Middlesex Hospital
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Stamford, Connecticut, United States, 06904
- The Stamford Hospital
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Florida
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Clearwater, Florida, United States, 33756
- Morton Plant Hospital
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Hollywood, Florida, United States, 33021
- Memorial Regional Hospital
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Hollywood, Florida, United States, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Hollywood, Florida, United States, 33021
- Breast Cancer Center at Memorial Regional Hospital
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Lakeland, Florida, United States, 33805
- Hollis Cancer Center
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Pembroke Pines, Florida, United States, 33028
- Memorial Cancer Institute at Memorial Hospital West
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Pembroke Pines, Florida, United States, 33028
- Memorial Hospital West
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Pembroke Pines, Florida, United States, 33028
- Breast Cancer Center at Memorial Hospital West
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Georgia
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Duluth, Georgia, United States, 30096
- The Center for Cancer Care-Duluth
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Lawrenceville, Georgia, United States, 30046
- Gwinnett Medical Center
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Snellville, Georgia, United States, 30078
- The Center for Cancer Care-Snellville
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Queen's Medical Center
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Honolulu, Hawaii, United States, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, United States, 96813
- Hawaii Cancer Care POB II
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Honolulu, Hawaii, United States, 96813
- Hawaii Oncology Inc POB I
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Honolulu, Hawaii, United States, 96817
- Hawaii Cancer Care Liliha
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Honolulu, Hawaii, United States, 96817
- Hawaii Oncology Inc Kuakini
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Idaho
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Post Falls, Idaho, United States, 83854
- Kootenai Health
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois
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Chicago, Illinois, United States, 60657
- Advocate Illinois Masonic Medical Center
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Danville, Illinois, United States, 61938
- Carle on Vermillion
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Effingham, Illinois, United States, 62401
- Carle - Effingham
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Evanston, Illinois, United States, 60201
- NorthShore University HealthSystem Evanston Hospital
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Glenview, Illinois, United States, 60026
- NorthShore University HealthSystem Glenbrook Hospital
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Highland Park, Illinois, United States, 60035
- NorthShore University HealthSystem Highland Park Hospital
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Mattoon, Illinois, United States, 61938
- Carle - Mattoon/Charleston
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Skokie, Illinois, United States, 60076
- NorthShore University HealthSystem Skokie ACC
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Urbana, Illinois, United States, 61801
- The Carle Foundation Hospital/Carle Cancer Center
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Indiana
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Indianapolis, Indiana, United States, 46237
- Franciscan St. Francis Health - Indianapolis
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Michigan City, Indiana, United States, 46360
- Woodland Cancer Care Center
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Mooresville, Indiana, United States, 46158
- Franciscan St. Francis Health - Mooresville
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Richmond, Indiana, United States, 47374
- Reid Health
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South Bend, Indiana, United States, 46601
- Memorial Hospital at South Bend
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Terre Haute, Indiana, United States, 47804
- Union Hospital
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Kentucky
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Edgewood, Kentucky, United States, 41017
- Saint Elizabeth Medical Center South
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Fort Thomas, Kentucky, United States, 41075
- Saint Elizabeth Medical Center Fort Thomas
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Lexington, Kentucky, United States, 40536
- Chandler Medical Center - University of Kentucky
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Louisville, Kentucky, United States, 40202
- James Graham Brown Cancer Center
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Louisville, Kentucky, United States, 40202
- University of Louisville Hospital
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Louisville, Kentucky, United States, 40202
- Norton Hospital
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Louisville, Kentucky, United States, 40202
- University of Louisville, Division of Surgical Oncology
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Louisville, Kentucky, United States, 40202
- University of Louisville Physicians, PSC
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Maine
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Bangor, Maine, United States, 04401
- Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
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Bethesda, Maryland, United States, 20889
- Walter Reed National Military Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02115
- Brigham & Women's Hospital
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Boston, Massachusetts, United States, 01757
- DF/BWCC at Milford Regional Medical Center
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Brighton, Massachusetts, United States, 02135
- St. Elizabeth's Medical Center
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Lowell, Massachusetts, United States, 01854
- Lowell General Hospital
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South Weymouth, Massachusetts, United States, 02190
- South Shore Hospital
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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Escanaba, Michigan, United States, 49829
- Green Bay Oncology, Ltd./St. Francis Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical Center, Fairview
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Minneapolis, Minnesota, United States, 55455
- Masonic Cancer Center University of Minnesota Medical Center
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Health: Clinics and Surgery Center
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Missouri
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Columbia, Missouri, United States, 65201
- Veterans Administration/Harry S Truman Memorial Hospital
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Columbia, Missouri, United States, 65212
- Ellis Fischel Cancer Center University of Missouri Healthcare
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, United States, 63129
- Siteman Cancer Center - South County
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Saint Louis, Missouri, United States, 63141
- Siteman Cancer Center - West County
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Saint Peters, Missouri, United States, 63376
- Siteman Cancer Center - St. Peters
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Montana
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Anaconda, Montana, United States, 59711
- Community Hospital of Anaconda
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Billings, Montana, United States, 59101
- Billings Clinic
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Billings, Montana, United States, 59102
- Montana Cancer Consortium
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Bozeman, Montana, United States, 59715
- Bozeman Health
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Great Falls, Montana, United States, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, United States, 59901
- Kalispell Regional Medical Center
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Missoula, Montana, United States, 59804
- Community Medical Center
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Nevada
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Las Vegas, Nevada, United States, 89148
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, United States, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
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Las Vegas, Nevada, United States, 89128
- Ann M Wierman MD LTD
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Las Vegas, Nevada, United States, 89102
- Nevada Cancer Specialists - Oakey
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Las Vegas, Nevada, United States, 89128
- Nevada Cancer Specialists - Tenaya
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Las Vegas, Nevada, United States, 89148
- Nevada Cancer Specialists - Fort Apache
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New Hampshire
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Concord, New Hampshire, United States, 03301
- New Hampshire Oncology - Hematology PA
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Hooksett, New Hampshire, United States, 03106
- New Hampshire Oncology-Hematology PA
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Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center
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Londonderry, New Hampshire, United States, 03053
- Dana-Farber/New Hampshire Oncology Hematology
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Hackensack, New Jersey, United States, 07601
- John Theurer Cancer Center at Hackensack University Medical Center
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- University of New Mexico Cancer Center
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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New York, New York, United States, 13210
- SUNY Upstate Medical University
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North Carolina
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Asheville, North Carolina, United States, 28801
- Mission Hospital - Memorial Campus
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Clinton, North Carolina, United States, 28328
- Southeastern Medical Oncology Center
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Durham, North Carolina, United States, 27710
- Duke University Health System
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Goldsboro, North Carolina, United States, 27534
- Southeastern Medical Oncology Center
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Greenville, North Carolina, United States, 27834
- East Carolina University
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Jacksonville, North Carolina, United States, 28546
- Southeastern Medical Oncology Center
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Kenansville, North Carolina, United States, 28349
- Kenansville Medical Center
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Kinston, North Carolina, United States, 28501
- Kinston Medical Specialists, P.A.
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Kinston, North Carolina, United States, 28501
- Lenoir Memorial Hospital
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Richlands, North Carolina, United States, 28574
- Onslow Medical Center
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Health
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Ohio
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Centerville, Ohio, United States, 45459
- Dayton Physicians LLC, Miami Valley South
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Columbus, Ohio, United States, 43210
- The James Cancer Hospital and Solove Research Institute
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Dayton, Ohio, United States, 45428
- Veteran Affairs Medical Center
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Dayton, Ohio, United States, 45415
- Dayton Physicians LLC, Samaritan North
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Dayton, Ohio, United States, 45420
- Dayton Clincial Oncology Program
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Dayton, Ohio, United States, 45433
- Wright Patterson Medical Center
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Franklin, Ohio, United States, 45005
- Dayton Physicians LLC, Atrium
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Greenville, Ohio, United States, 45331
- Dayton Physicians, Wayne
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Kettering, Ohio, United States, 45429
- Kettering Medical Center
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Kettering, Ohio, United States, 45409
- Greater Dayton Cancer Center
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Maumee, Ohio, United States, 43537
- Toledo Clinic Cancer Center - Maumee
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Toledo, Ohio, United States, 43623
- Toledo Clinic Cancer Center - Toledo
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Troy, Ohio, United States, 45373
- Dayton Physicians LLC, Upper valley
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Pennsylvania
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Ephrata, Pennsylvania, United States, 17522
- WellSpan Health Ephrata Cancer Center
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Gettysburg, Pennsylvania, United States, 17325
- WellSpan Health Adams Cancer Center
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Lebanon, Pennsylvania, United States, 17042
- WellSpan Health Sechler Family Cancer Center
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Pittsburgh, Pennsylvania, United States, 15224
- Western Pennsylvania Hospital
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York, Pennsylvania, United States, 17403
- WellSpan Health York Cancer Center
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
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Dallas, Texas, United States, 75246
- Baylor University Medical Center
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Dallas, Texas, United States, 75204
- Baylor Scott & White Research Institute
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Vermont
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Burlington, Vermont, United States, 05401
- University of Vermont Medical Center
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Virginia
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Fishersville, Virginia, United States, 22939
- Augusta Health Cancer Center
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Fort Belvoir, Virginia, United States, 22060
- Fort Belvoir Community Hospital
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Mechanicsville, Virginia, United States, 23116
- Bon Secours Cancer Institute Medical Oncology at Memorial Regional
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Midlothian, Virginia, United States, 23114
- Bon Secours Cancer Institute Medical Oncology at St. Francis
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Richmond, Virginia, United States, 23226
- Bon Secours Cancer Institute Medical Oncology at St. Mary's
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Washington
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Auburn, Washington, United States, 98001
- MultiCare Regional Cancer Center - Auburn
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Gig Harbor, Washington, United States, 98335
- MultiCare Regional Cancer Center - Gig Harbor Medical Park
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Puyallup, Washington, United States, 98372
- MultiCare Regional Cancer Center - Puyallup
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Tacoma, Washington, United States, 98405
- MultiCare Institute for Research & Innovation
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Tacoma, Washington, United States, 98405
- MultiCare Regional Cancer Center - Tacoma
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Wisconsin
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Green Bay, Wisconsin, United States, 54301
- HSHS St. Vincent Hospital
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Green Bay, Wisconsin, United States, 54301
- Green Bay Oncology, Ltd./HSHS St. Vincent Hospital
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Green Bay, Wisconsin, United States, 54303
- Green Bay Oncology, Ltd./HSHS St. Mary's Hospital Medical Center
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Green Bay, Wisconsin, United States, 54303
- HSHS St. Mary's Hospital Medical Center
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La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Medical Center
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Madison, Wisconsin, United States, 53792
- University of Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Oconto Falls, Wisconsin, United States, 54154
- Green Bay Oncology, Ltd./HSHS St. Clare Memorial Hospital
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Sturgeon Bay, Wisconsin, United States, 54135
- Green Bay Oncology, Ltd./Door County Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of advanced solid tumor cancer, lymphoma, or myeloma (no time restrictions or limitations) -OR- diagnosis of early stage solid tumor cancer, lymphoma, or myeloma <= 12 months prior to study enrollment
Diagnosis of VTE <= 30 days prior to study enrollment for which potential benefits of anticoagulation therapy to prevent recurrence of VTE are felt by the treating physician to exceed the potential harms
- Any anticoagulation drug/strategy may be used to treat the index VTE; protocol treatment will begin <= 30days after the index VTE diagnosis date
- Treating physician intends to put participant on anticoagulation therapy for at least three months.
- Age >= 18 years
- Platelet count is >= 50,000/mm^3 (<= 7 days prior to enrollment)
- CrCl (Creatinine Clearance) is >= 15 ml/min (<= 7 days prior to enrollment)
Exclusion Criteria:
- Diagnosis of acute leukemia
Has ever received or is scheduled to receive an Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
- Patients who have ever received an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) ARE eligible.
- Patients who are scheduled to receive an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) are NOT eligible
- Ongoing, clinically significant bleeding (CTCAE grade 3 or 4)
- Ongoing therapy with a P-gp inhibitor (e.g., nelfinavir, indinavir, or saquinavir-protease inhibitors for HIV) as these drugs interact with the factor Xa inhibitors
- Therapy with any azole antifungals (e.g., itraconazole, ketaconazole, voriconazole) at the time of enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Randomized Arm 1 (DOACs)
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.
|
Anticoagulation therapy.
Other Names:
Anticoagulation therapy.
Other Names:
Anticoagulation therapy.
Other Names:
Anticoagulation therapy.
Other Names:
|
Active Comparator: Randomized Arm 2 (LMWH)
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.
|
Anticoagulation therapy.
Other Names:
Anticoagulation therapy.
Other Names:
Anticoagulation therapy.
Other Names:
Anticoagulation therapy.
Other Names:
|
Active Comparator: Preference Cohort 1 (DOACs)
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). |
Anticoagulation therapy.
Other Names:
Anticoagulation therapy.
Other Names:
Anticoagulation therapy.
Other Names:
Anticoagulation therapy.
Other Names:
|
Active Comparator: Preference Cohort 2 (LMWH)
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 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin. |
Anticoagulation therapy.
Other Names:
Anticoagulation therapy.
Other Names:
Anticoagulation therapy.
Other Names:
Anticoagulation therapy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative Non-Fatal VTE Recurrence at 6 Months (%)
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.
Only VTEs that were nonfatal were considered because of the challenges of attributing cause of death in cancer patients to tumor progression vs. VTE.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative Rates of Major Bleeding
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.
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).
|
6 months
|
Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
Time Frame: 3 months
|
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.
|
3 months
|
Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
Time Frame: 3 months
|
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).
|
3 months
|
Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)
Time Frame: 6 months
|
To compare the impact of DOAC vs. LMWH/warfarin therapy on mortality in cancer patients with VTE based on survival at 6 months.
Mortality was reported by participants' surrogates (via study-specific questionnaire) or clinicians (via study-specific case report form)
|
6 months
|
Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
Time Frame: 6 months
|
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.
|
6 months
|
Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
Time Frame: 6 months
|
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).
|
6 months
|
Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
Time Frame: 3-months
|
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).
|
3-months
|
Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
Time Frame: 6-months
|
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).
|
6-months
|
Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 3-months
Time Frame: 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.
|
3-months
|
Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 6-months
Time Frame: 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.
|
6-months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Deborah Schrag, MD MPH, Alliance Foundation Trials, LLC.
- Study Chair: Jean Connors, MD, Alliance Foundation Trials, LLC.
Publications and helpful links
Helpful Links
- FDA Package Insert for Rivaroxaban (Xarelto)
- FDA Package Insert for Apixaban (Eliquis)
- FDA Package Insert for Edoxaban (Savaysa)
- FDA Package Insert for Dabigatran (Pradaxa)
- FDA Package Insert for Dalteparin (Fragmin)
- FDA Package Insert for Enoxaparin (Lovenox)
- FDA Package Insert for Fondaparinux (Arixtra)
- FDA Package Insert for Warfarin (Coumadin)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Embolism and Thrombosis
- Embolism
- Thrombosis
- Venous Thrombosis
- Thromboembolism
- Venous Thromboembolism
- Pulmonary Embolism
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Rivaroxaban
- Dabigatran
- Apixaban
- Edoxaban
- Enoxaparin
- Dalteparin
- Warfarin
- Fondaparinux
- PENTA
Other Study ID Numbers
- AFT-28
- CER-1503-29805 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Study Data/Documents
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Study Protocol
Information identifier: AFT-28Information comments: Email the study team at CANVAS@AllianceFoundationTrials.org.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
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University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
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Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
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UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
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Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
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MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
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University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
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Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on Rivaroxaban
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Portola PharmaceuticalsCompleted
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Korea University Anam HospitalRecruitingAtrial Fibrillation | Anticoagulant Adverse ReactionKorea, Republic of
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Doasense GmbHActive, not recruitingAnticoagulant TherapyGermany
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China National Center for Cardiovascular DiseasesNot yet recruitingStroke | Atrial Fibrillation | Major Adverse Cardiac Events | Anticoagulant Adverse Reaction
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BayerCompleted
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The Affiliated Hospital of Qingdao UniversityCompletedHealthy SubjectsChina
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BayerJanssen R&D, L.L.C.Completed
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BayerJanssen Research & Development, LLCCompletedCoronary Artery Disease | Cardiovascular DiseaseBelgium, Netherlands
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University Hospital, GrenobleCompleted
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Addpharma Inc.CompletedEmbolism and ThrombosisKorea, Republic of