Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer
NCT ID: NCT02744092
Last Updated: 2023-10-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
811 participants
INTERVENTIONAL
2016-12-13
2021-02-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
DOAC - Dosing Options in AntiCoagulation Prophylaxis
NCT07005024
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort
NCT04979780
Cancer Venous Thromboembolism (VTE)
NCT02073682
Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients
NCT02706249
Prophylactic Anticoagulation for Catheter-related Thrombosis
NCT04256525
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Rivaroxaban
Anticoagulation therapy.
Apixaban
Anticoagulation therapy.
Edoxaban
Anticoagulation therapy.
Dabigatran
Anticoagulation therapy.
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.
Warfarin
Anticoagulation therapy.
Dalteparin
Anticoagulation therapy.
Enoxaparin
Anticoagulation therapy.
Fondaparinux
Anticoagulation therapy.
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).
Rivaroxaban
Anticoagulation therapy.
Apixaban
Anticoagulation therapy.
Edoxaban
Anticoagulation therapy.
Dabigatran
Anticoagulation therapy.
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.
Warfarin
Anticoagulation therapy.
Dalteparin
Anticoagulation therapy.
Enoxaparin
Anticoagulation therapy.
Fondaparinux
Anticoagulation therapy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rivaroxaban
Anticoagulation therapy.
Apixaban
Anticoagulation therapy.
Edoxaban
Anticoagulation therapy.
Dabigatran
Anticoagulation therapy.
Warfarin
Anticoagulation therapy.
Dalteparin
Anticoagulation therapy.
Enoxaparin
Anticoagulation therapy.
Fondaparinux
Anticoagulation therapy.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Patient-Centered Outcomes Research Institute
OTHER
Alliance Foundation Trials, LLC.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Deborah Schrag, MD MPH
Role: STUDY_CHAIR
Alliance Foundation Trials, LLC.
Jean Connors, MD
Role: STUDY_CHAIR
Alliance Foundation Trials, LLC.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
South County Hematology
Chula Vista, California, United States
Sharp Rees-Stealy
Chula Vista, California, United States
Washington Hospital Healthcare System
Fremont, California, United States
Washington Hospital
Fremont, California, United States
VA Central California Fresno Medical Center
Fresno, California, United States
Cancer Center Oncology Medical Group
La Mesa, California, United States
Medical Oncology Associates- San Diego
San Diego, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Sharp Rees-Stealy
San Diego, California, United States
UCSF Medical Center - Mission Bay
San Francisco, California, United States
Saint Joseph's Medical Center
Stockton, California, United States
Middlesex Hospital
Middletown, Connecticut, United States
The Stamford Hospital
Stamford, Connecticut, United States
Morton Plant Hospital
Clearwater, Florida, United States
Breast Cancer Center at Memorial Regional Hospital
Hollywood, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Hollis Cancer Center
Lakeland, Florida, United States
Breast Cancer Center at Memorial Hospital West
Pembroke Pines, Florida, United States
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida, United States
Memorial Hospital West
Pembroke Pines, Florida, United States
The Center for Cancer Care-Duluth
Duluth, Georgia, United States
Gwinnett Medical Center
Lawrenceville, Georgia, United States
The Center for Cancer Care-Snellville
Snellville, Georgia, United States
Hawaii Cancer Care POB II
Honolulu, Hawaii, United States
Hawaii Oncology Inc POB I
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Hawaii Cancer Care Liliha
Honolulu, Hawaii, United States
Hawaii Oncology Inc Kuakini
Honolulu, Hawaii, United States
Kootenai Health
Post Falls, Idaho, United States
University of Illinois
Chicago, Illinois, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Carle on Vermillion
Danville, Illinois, United States
Carle - Effingham
Effingham, Illinois, United States
NorthShore University HealthSystem Evanston Hospital
Evanston, Illinois, United States
NorthShore University HealthSystem Glenbrook Hospital
Glenview, Illinois, United States
NorthShore University HealthSystem Highland Park Hospital
Highland Park, Illinois, United States
Carle - Mattoon/Charleston
Mattoon, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
NorthShore University HealthSystem Skokie ACC
Skokie, Illinois, United States
The Carle Foundation Hospital/Carle Cancer Center
Urbana, Illinois, United States
Franciscan St. Francis Health - Indianapolis
Indianapolis, Indiana, United States
Woodland Cancer Care Center
Michigan City, Indiana, United States
Franciscan St. Francis Health - Mooresville
Mooresville, Indiana, United States
Reid Health
Richmond, Indiana, United States
Memorial Hospital at South Bend
South Bend, Indiana, United States
Union Hospital
Terre Haute, Indiana, United States
Saint Elizabeth Medical Center South
Edgewood, Kentucky, United States
Saint Elizabeth Medical Center Fort Thomas
Fort Thomas, Kentucky, United States
Chandler Medical Center - University of Kentucky
Lexington, Kentucky, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Norton Hospital
Louisville, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
University of Louisville Physicians, PSC
Louisville, Kentucky, United States
University of Louisville, Division of Surgical Oncology
Louisville, Kentucky, United States
Eastern Maine Medical Center
Bangor, Maine, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
DF/BWCC at Milford Regional Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
St. Elizabeth's Medical Center
Brighton, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
South Shore Hospital
South Weymouth, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Green Bay Oncology, Ltd./St. Francis Hospital
Escanaba, Michigan, United States
Masonic Cancer Center University of Minnesota Medical Center
Minneapolis, Minnesota, United States
University of Minnesota Health: Clinics and Surgery Center
Minneapolis, Minnesota, United States
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States
Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, United States
Veterans Administration/Harry S Truman Memorial Hospital
Columbia, Missouri, United States
Ellis Fischel Cancer Center University of Missouri Healthcare
Columbia, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
Siteman Cancer Center - West County
St Louis, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic
Billings, Montana, United States
Montana Cancer Consortium
Billings, Montana, United States
Bozeman Health
Bozeman, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Nevada Cancer Specialists - Oakey
Las Vegas, Nevada, United States
Ann M Wierman MD LTD
Las Vegas, Nevada, United States
Nevada Cancer Specialists - Tenaya
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Nevada Cancer Specialists - Fort Apache
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
New Hampshire Oncology - Hematology PA
Concord, New Hampshire, United States
New Hampshire Oncology-Hematology PA
Hooksett, New Hampshire, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Dana-Farber/New Hampshire Oncology Hematology
Londonderry, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
SUNY Upstate Medical University
New York, New York, United States
Mission Hospital - Memorial Campus
Asheville, North Carolina, United States
Southeastern Medical Oncology Center
Clinton, North Carolina, United States
Duke University Health System
Durham, North Carolina, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Southeastern Medical Oncology Center
Jacksonville, North Carolina, United States
Kenansville Medical Center
Kenansville, North Carolina, United States
Kinston Medical Specialists, P.A.
Kinston, North Carolina, United States
Lenoir Memorial Hospital
Kinston, North Carolina, United States
Onslow Medical Center
Richlands, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Dayton Physicians LLC, Miami Valley South
Centerville, Ohio, United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
Dayton Physicians LLC, Samaritan North
Dayton, Ohio, United States
Dayton Clincial Oncology Program
Dayton, Ohio, United States
Veteran Affairs Medical Center
Dayton, Ohio, United States
Wright Patterson Medical Center
Dayton, Ohio, United States
Dayton Physicians LLC, Atrium
Franklin, Ohio, United States
Dayton Physicians, Wayne
Greenville, Ohio, United States
Greater Dayton Cancer Center
Kettering, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Toledo Clinic Cancer Center - Maumee
Maumee, Ohio, United States
Toledo Clinic Cancer Center - Toledo
Toledo, Ohio, United States
Dayton Physicians LLC, Upper valley
Troy, Ohio, United States
WellSpan Health Ephrata Cancer Center
Ephrata, Pennsylvania, United States
WellSpan Health Adams Cancer Center
Gettysburg, Pennsylvania, United States
WellSpan Health Sechler Family Cancer Center
Lebanon, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
WellSpan Health York Cancer Center
York, Pennsylvania, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Augusta Health Cancer Center
Fishersville, Virginia, United States
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States
Bon Secours Cancer Institute Medical Oncology at Memorial Regional
Mechanicsville, Virginia, United States
Bon Secours Cancer Institute Medical Oncology at St. Francis
Midlothian, Virginia, United States
Bon Secours Cancer Institute Medical Oncology at St. Mary's
Richmond, Virginia, United States
MultiCare Regional Cancer Center - Auburn
Auburn, Washington, United States
MultiCare Regional Cancer Center - Gig Harbor Medical Park
Gig Harbor, Washington, United States
MultiCare Regional Cancer Center - Puyallup
Puyallup, Washington, United States
Multicare Institute for Research & Innovation
Tacoma, Washington, United States
MultiCare Regional Cancer Center - Tacoma
Tacoma, Washington, United States
Green Bay Oncology, Ltd./HSHS St. Vincent Hospital
Green Bay, Wisconsin, United States
HSHS St. Vincent Hospital
Green Bay, Wisconsin, United States
Green Bay Oncology, Ltd./HSHS St. Mary's Hospital Medical Center
Green Bay, Wisconsin, United States
HSHS St. Mary's Hospital Medical Center
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Green Bay Oncology, Ltd./HSHS St. Clare Memorial Hospital
Oconto Falls, Wisconsin, United States
Green Bay Oncology, Ltd./Door County Memorial Hospital
Sturgeon Bay, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Schrag D, Uno H, Rosovsky R, Rutherford C, Sanfilippo K, Villano JL, Drescher M, Jayaram N, Holmes C, Feldman L, Zattra O, Farrar-Muir H, Cronin C, Basch E, Weiss A, Connors JM; CANVAS Investigators. Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin and Recurrent VTE in Patients With Cancer: A Randomized Clinical Trial. JAMA. 2023 Jun 13;329(22):1924-1933. doi: 10.1001/jama.2023.7843.
Riaz IB, Fuentes HE, Naqvi SAA, He H, Sipra QR, Tafur AJ, Padranos L, Wysokinski WE, Marshall AL, Vandvik PO, Montori V, Bryce AH, Liu H, Badgett RG, Murad MH, McBane RD 2nd. Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis. Mayo Clin Proc. 2022 Feb;97(2):308-324. doi: 10.1016/j.mayocp.2020.10.041. Epub 2021 Jun 22.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Related Links
Access external resources that provide additional context or updates about the study.
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)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CER-1503-29805
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AFT-28
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.