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| ID | Type | Description | Link |
|---|---|---|---|
| CER-1503-29805 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute (PCORI) |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized Arm 1 (DOACs) | Active Comparator | 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. |
|
| Randomized Arm 2 (LMWH) | Active Comparator | 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. |
|
| Preference Cohort 1 (DOACs) | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | Anticoagulation therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Non-Fatal VTE Recurrence at 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Rates of Major Bleeding | 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). |
Not provided
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
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)
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
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Schrag, MD MPH | Alliance Foundation Trials, LLC. | Study Chair |
| Jean Connors, MD | Alliance Foundation Trials, LLC. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South County Hematology | Chula Vista | California | 91911 | United States | ||
| Sharp Rees-Stealy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37266947 | Derived | 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. | |
| 34172290 |
| Label | URL |
|---|---|
| FDA Package Insert for Rivaroxaban (Xarelto) | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| AFT-28 | Study Protocol | View IPD |
Individual-level de-identified datasets will be made available to investigators working under an institution with a Federal Wide Assurance (FWA) who formally submit a request to the study chairs at the Dana-Farber Cancer Institute. Prior to the release of datasets, DFCI will ensure certain requirements, e.g., IRB approval and data use agreement, are in place. These datasets will be available within 6 months of publication of the manuscript and following a formal request by an investigator to and approval from DFCI.
within 6 months of publication of the manuscript, no end date
following a formal request by an investigator to and approval from DFCI
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Patients were recruited from 67 US-based healthcare institutions between December 2016 and April 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrolled & Received Selected Treatment |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2021 |
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| Preference Cohort 2 (LMWH) | Active Comparator | 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. |
|
| Apixaban | Drug | Anticoagulation therapy. |
|
|
| Edoxaban | Drug | Anticoagulation therapy. |
|
|
| Dabigatran | Drug | Anticoagulation therapy. |
|
|
| Warfarin | Drug | Anticoagulation therapy. |
|
|
| Dalteparin | Drug | Anticoagulation therapy. |
|
|
| Enoxaparin | Drug | Anticoagulation therapy. |
|
|
| Fondaparinux | Drug | Anticoagulation therapy. |
|
|
| 6 months |
| Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Chula Vista |
| California |
| 91913 |
| United States |
| Washington Hospital Healthcare System | Fremont | California | 94538 | United States |
| Washington Hospital | Fremont | California | 94538 | United States |
| VA Central California Fresno Medical Center | Fresno | California | 93073 | United States |
| Cancer Center Oncology Medical Group | La Mesa | California | 91942 | United States |
| Medical Oncology Associates- San Diego | San Diego | California | 92123 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| Sharp Rees-Stealy | San Diego | California | 92123 | United States |
| UCSF Medical Center - Mission Bay | San Francisco | California | 94143 | United States |
| Saint Joseph's Medical Center | Stockton | California | 95204 | United States |
| Middlesex Hospital | Middletown | Connecticut | 06457 | United States |
| The Stamford Hospital | Stamford | Connecticut | 06904 | United States |
| Morton Plant Hospital | Clearwater | Florida | 33756 | United States |
| Breast Cancer Center at Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Hollis Cancer Center | Lakeland | Florida | 33805 | United States |
| Breast Cancer Center at Memorial Hospital West | Pembroke Pines | Florida | 33028 | United States |
| Memorial Cancer Institute at Memorial Hospital West | Pembroke Pines | Florida | 33028 | United States |
| Memorial Hospital West | Pembroke Pines | Florida | 33028 | United States |
| The Center for Cancer Care-Duluth | Duluth | Georgia | 30096 | United States |
| Gwinnett Medical Center | Lawrenceville | Georgia | 30046 | United States |
| The Center for Cancer Care-Snellville | Snellville | Georgia | 30078 | United States |
| Hawaii Cancer Care POB II | Honolulu | Hawaii | 96813 | United States |
| Hawaii Oncology Inc POB I | Honolulu | Hawaii | 96813 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
| Hawaii Cancer Care Liliha | Honolulu | Hawaii | 96817 | United States |
| Hawaii Oncology Inc Kuakini | Honolulu | Hawaii | 96817 | United States |
| Kootenai Health | Post Falls | Idaho | 83854 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| Advocate Illinois Masonic Medical Center | Chicago | Illinois | 60657 | United States |
| Carle on Vermillion | Danville | Illinois | 61938 | United States |
| Carle - Effingham | Effingham | Illinois | 62401 | United States |
| NorthShore University HealthSystem Evanston Hospital | Evanston | Illinois | 60201 | United States |
| NorthShore University HealthSystem Glenbrook Hospital | Glenview | Illinois | 60026 | United States |
| NorthShore University HealthSystem Highland Park Hospital | Highland Park | Illinois | 60035 | United States |
| Carle - Mattoon/Charleston | Mattoon | Illinois | 61938 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| NorthShore University HealthSystem Skokie ACC | Skokie | Illinois | 60076 | United States |
| The Carle Foundation Hospital/Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Franciscan St. Francis Health - Indianapolis | Indianapolis | Indiana | 46237 | United States |
| Woodland Cancer Care Center | Michigan City | Indiana | 46360 | United States |
| Franciscan St. Francis Health - Mooresville | Mooresville | Indiana | 46158 | United States |
| Reid Health | Richmond | Indiana | 47374 | United States |
| Memorial Hospital at South Bend | South Bend | Indiana | 46601 | United States |
| Union Hospital | Terre Haute | Indiana | 47804 | United States |
| Saint Elizabeth Medical Center South | Edgewood | Kentucky | 41017 | United States |
| Saint Elizabeth Medical Center Fort Thomas | Fort Thomas | Kentucky | 41075 | United States |
| Chandler Medical Center - University of Kentucky | Lexington | Kentucky | 40536 | United States |
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Norton Hospital | Louisville | Kentucky | 40202 | United States |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| University of Louisville Physicians, PSC | Louisville | Kentucky | 40202 | United States |
| University of Louisville, Division of Surgical Oncology | Louisville | Kentucky | 40202 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| DF/BWCC at Milford Regional Medical Center | Boston | Massachusetts | 01757 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| St. Elizabeth's Medical Center | Brighton | Massachusetts | 02135 | United States |
| Lowell General Hospital | Lowell | Massachusetts | 01854 | United States |
| South Shore Hospital | South Weymouth | Massachusetts | 02190 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Green Bay Oncology, Ltd./St. Francis Hospital | Escanaba | Michigan | 49829 | United States |
| Masonic Cancer Center University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
| University of Minnesota Health: Clinics and Surgery Center | Minneapolis | Minnesota | 55455 | United States |
| University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | 55455 | United States |
| Siteman Cancer Center - St. Peters | City of Saint Peters | Missouri | 63376 | United States |
| Veterans Administration/Harry S Truman Memorial Hospital | Columbia | Missouri | 65201 | United States |
| Ellis Fischel Cancer Center University of Missouri Healthcare | Columbia | Missouri | 65212 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center - South County | St Louis | Missouri | 63129 | United States |
| Siteman Cancer Center - West County | St Louis | Missouri | 63141 | United States |
| Community Hospital of Anaconda | Anaconda | Montana | 59711 | United States |
| Billings Clinic | Billings | Montana | 59101 | United States |
| Montana Cancer Consortium | Billings | Montana | 59102 | United States |
| Bozeman Health | Bozeman | Montana | 59715 | United States |
| Benefis Sletten Cancer Institute | Great Falls | Montana | 59405 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Community Medical Center | Missoula | Montana | 59804 | United States |
| Nevada Cancer Specialists - Oakey | Las Vegas | Nevada | 89102 | United States |
| Ann M Wierman MD LTD | Las Vegas | Nevada | 89128 | United States |
| Nevada Cancer Specialists - Tenaya | Las Vegas | Nevada | 89128 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | United States |
| Nevada Cancer Specialists - Fort Apache | Las Vegas | Nevada | 89148 | United States |
| Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada | 89169 | United States |
| New Hampshire Oncology - Hematology PA | Concord | New Hampshire | 03301 | United States |
| New Hampshire Oncology-Hematology PA | Hooksett | New Hampshire | 03106 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Dana-Farber/New Hampshire Oncology Hematology | Londonderry | New Hampshire | 03053 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87102 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| SUNY Upstate Medical University | New York | New York | 13210 | United States |
| Mission Hospital - Memorial Campus | Asheville | North Carolina | 28801 | United States |
| Southeastern Medical Oncology Center | Clinton | North Carolina | 28328 | United States |
| Duke University Health System | Durham | North Carolina | 27710 | United States |
| Southeastern Medical Oncology Center | Goldsboro | North Carolina | 27534 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Southeastern Medical Oncology Center | Jacksonville | North Carolina | 28546 | United States |
| Kenansville Medical Center | Kenansville | North Carolina | 28349 | United States |
| Kinston Medical Specialists, P.A. | Kinston | North Carolina | 28501 | United States |
| Lenoir Memorial Hospital | Kinston | North Carolina | 28501 | United States |
| Onslow Medical Center | Richlands | North Carolina | 28574 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| Dayton Physicians LLC, Miami Valley South | Centerville | Ohio | 45459 | United States |
| The James Cancer Hospital and Solove Research Institute | Columbus | Ohio | 43210 | United States |
| Dayton Physicians LLC, Samaritan North | Dayton | Ohio | 45415 | United States |
| Dayton Clincial Oncology Program | Dayton | Ohio | 45420 | United States |
| Veteran Affairs Medical Center | Dayton | Ohio | 45428 | United States |
| Wright Patterson Medical Center | Dayton | Ohio | 45433 | United States |
| Dayton Physicians LLC, Atrium | Franklin | Ohio | 45005 | United States |
| Dayton Physicians, Wayne | Greenville | Ohio | 45331 | United States |
| Greater Dayton Cancer Center | Kettering | Ohio | 45409 | United States |
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
| Toledo Clinic Cancer Center - Maumee | Maumee | Ohio | 43537 | United States |
| Toledo Clinic Cancer Center - Toledo | Toledo | Ohio | 43623 | United States |
| Dayton Physicians LLC, Upper valley | Troy | Ohio | 45373 | United States |
| WellSpan Health Ephrata Cancer Center | Ephrata | Pennsylvania | 17522 | United States |
| WellSpan Health Adams Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| WellSpan Health Sechler Family Cancer Center | Lebanon | Pennsylvania | 17042 | United States |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| WellSpan Health York Cancer Center | York | Pennsylvania | 17403 | United States |
| Baylor Scott & White Research Institute | Dallas | Texas | 75204 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Augusta Health Cancer Center | Fishersville | Virginia | 22939 | United States |
| Fort Belvoir Community Hospital | Fort Belvoir | Virginia | 22060 | United States |
| Bon Secours Cancer Institute Medical Oncology at Memorial Regional | Mechanicsville | Virginia | 23116 | United States |
| Bon Secours Cancer Institute Medical Oncology at St. Francis | Midlothian | Virginia | 23114 | United States |
| Bon Secours Cancer Institute Medical Oncology at St. Mary's | Richmond | Virginia | 23226 | United States |
| MultiCare Regional Cancer Center - Auburn | Auburn | Washington | 98001 | United States |
| MultiCare Regional Cancer Center - Gig Harbor Medical Park | Gig Harbor | Washington | 98335 | United States |
| MultiCare Regional Cancer Center - Puyallup | Puyallup | Washington | 98372 | United States |
| Multicare Institute for Research & Innovation | Tacoma | Washington | 98405 | United States |
| MultiCare Regional Cancer Center - Tacoma | Tacoma | Washington | 98405 | United States |
| Green Bay Oncology, Ltd./HSHS St. Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| HSHS St. Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| Green Bay Oncology, Ltd./HSHS St. Mary's Hospital Medical Center | Green Bay | Wisconsin | 54303 | United States |
| HSHS St. Mary's Hospital Medical Center | Green Bay | Wisconsin | 54303 | United States |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Green Bay Oncology, Ltd./HSHS St. Clare Memorial Hospital | Oconto Falls | Wisconsin | 54154 | United States |
| Green Bay Oncology, Ltd./Door County Memorial Hospital | Sturgeon Bay | Wisconsin | 54135 | United States |
| Derived |
| 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. |
| FDA Package Insert for Apixaban (Eliquis) | View source |
| FDA Package Insert for Edoxaban (Savaysa) | View source |
| FDA Package Insert for Dabigatran (Pradaxa) | View source |
| FDA Package Insert for Dalteparin (Fragmin) | View source |
| FDA Package Insert for Enoxaparin (Lovenox) | View source |
| FDA Package Insert for Fondaparinux (Arixtra) | View source |
| FDA Package Insert for Warfarin (Coumadin) | View source |
Email the study team at CANVAS@AllianceFoundationTrials.org. |
| FG001 | 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. Dalteparin: Anticoagulation therapy. Enoxaparin: Anticoagulation therapy. Fondaparinux: Anticoagulation therapy. |
| FG002 | 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. |
| FG003 | 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. Dalteparin: Anticoagulation therapy. Enoxaparin: Anticoagulation therapy. Fondaparinux: Anticoagulation therapy. |
| Received Assigned Treatment (Apixaban) |
|
| Received Assigned Treatment (Rivaroxaban) |
|
| Received Assigned Treatment (Dabigatran) |
|
| Received Assigned Treatment (Edoxaban) |
|
| Received Assigned Treatment (Enoxaparin) |
|
| Received Assigned Treatment (Fondaparinux) |
|
| Received Assigned Treatment (Dalteparin) |
|
| Did Not Receive Assigned/Selected Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| 6-Month Clinical Outcomes(Chart Review) |
|
| 3-Month Patient-Reported Outcomes Survey |
|
| 6-Month Patient-Reported Outcomes Survey |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. Dalteparin: Anticoagulation therapy. Enoxaparin: Anticoagulation therapy. Fondaparinux: Anticoagulation therapy. |
| BG002 | 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. |
| BG003 | 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. Dalteparin: Anticoagulation therapy. Enoxaparin: Anticoagulation therapy. Fondaparinux: Anticoagulation therapy. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Customized | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Non-Fatal VTE Recurrence at 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. | Primary analyses were performed on the participants who began protocol-directed therapy, the "as treated" population. | Posted | Number | percentage of patients | 6 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Rates of Major Bleeding | 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). | Primary analyses were performed on the participants who began protocol-directed therapy, the "as treated" population. | Posted | Number | percentage of patients | 6 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire | 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. | Participants completing the 3-month survey assessment | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire | 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). | Participants completing the 3-month survey assessment | Posted | Mean | 95% Confidence Interval | score on a scale | 3 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form) | 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) | Primary analyses were performed on the participants who began protocol-directed therapy, the "as treated" population. | Posted | Number | percentage of patients | 6 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire | 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. | Participants completing the 6-month survey assessment | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire | 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). | Participants completing the 6-month survey assessment | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire | 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). | Participants completing the 3-month survey assessment | Posted | Mean | 95% Confidence Interval | score on a scale | 3-months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire | 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). | Participants completing the 6-moth survey assessment | Posted | Mean | 95% Confidence Interval | score on a scale | 6-months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 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. | Participants completing the 3-month survey assessment | Posted | Mean | 95% Confidence Interval | units on a scale | 3-months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 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. | Participants completing the 6-month survey assessment | Posted | Mean | 95% Confidence Interval | units on a scale | 6-months |
|
Adverse event (AE) data was collected for 6-months.
AEs were reported by physicians. Grade 3+ AEs were severe. Other AEs are grade 1 or 2 . Other AE section reports on events that were experienced in >1% of patients, so total # of patients may not match the # of patients experiencing events. We did not report AEs by individual drug arm because we did not randomize drugs; comparisons amongst drugs will be subject to selection bias. Also, the protocol allowed patients to switch drugs, so it would be unclear which AE is affiliated with which drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 70 | 330 | 123 | 330 | 6 | 330 |
| EG001 | 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. | 56 | 308 | 114 | 308 | 11 | 308 |
| EG002 | 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. | 18 | 107 | 51 | 107 | 3 | 107 |
| EG003 | 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. | 9 | 30 | 16 | 30 | 2 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Atrial flutter | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Cardiac arrest | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Heart failure | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Pericardial effusion | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Pericardial tamponade | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Hypothyroidism | Endocrine disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Eye disorders - Other, specify | Eye disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Ascites | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Colitis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Colonic obstruction | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Colonic | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Gastric hemorrhage | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Gastric ulcer | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Lower GI hemorrhage | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Obstruction gastric | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Pancreatitis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Rectal pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Death NOS | General disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Edema limbs | General disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Fatigue | General disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Fever | General disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Multi-organ failure | General disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Non-cardiac chest pain | General disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Pain | General disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Sudden death NOS | General disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Generalized edema | General disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Disease progression | General disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Allergic reaction | Immune system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Abdominal infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Biliary tract infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Breast infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Enterocolitis infectious | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Joint infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Lung infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Peritoneal infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Sepsis | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Skin infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Urinary tract infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Intestinal stoma site bleeding | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Blood bilirubin increased | Investigations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| GGT increased | Investigations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| INR incresed | Investigations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Lymphocyte count decreased | Investigations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Neutrophil count decreased | Investigations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Platelet count decreased | Investigations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| White blood cell decreased | Investigations | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Soft tissue necrosis lower limb | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Tumor hemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Dizziness | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Edema cerebral | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Facial muscle weakness | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Headache | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Hydrocephalus | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Intracranial hemorrhage | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Ischemia cerebrovascular | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Seizure | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Somnolence | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Stroke | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Syncope | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Spinal cord compression | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Confusion | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Delirium | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Suicidal ideation | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Hematuria | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Uterine hemorrhage | Reproductive system and breast disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Vaginal inflammation | Reproductive system and breast disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Hematoma | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Hypertension | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Hypotension | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Thromboembolic event | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Vascular disorders - Other, specify | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Arterial thromboembolism | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 3+ |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Blurred vision | Eye disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Constipation | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Fever | General disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Dizziness | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Seizure | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Stroke | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Confusion | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
| Thromboembolic event | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment | Grade 1 or 2 |
|
This study has several limitations. First, participants and physicians were not blinded to treatment assignment. Second, because participants were randomized within 30 days of a new VTE diagnosis, some were treated with different therapy before randomization. Third, in patients with advanced-stage cancer, it was not possible to distinguish VTE from cancer as the cause of death. Fourth, the included population limits generalizability. Fifth, detailed medication diaries were not obtained.
Complete study results are available in JAMA.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jean Connors | Dana-Farber Cancer Institute | (617) 632-3000 | jconnors@bwh.harvard.edu |
| Apr 4, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| C552171 | edoxaban |
| D000069604 | Dabigatran |
| D014859 | Warfarin |
| D017985 | Dalteparin |
| D017984 | Enoxaparin |
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D009844 | Oligosaccharides |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|