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Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer
Trial Status: complete
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.
Inclusion Criteria
Diagnosis of advanced solid tumor cancer, lymphoma, or myeloma (no time restrictions or limitations) -OR- diagnosis of early stage solid tumor cancer, lymphoma, or myeloma <= 12 months prior to study enrollment
Diagnosis of VTE <= 30 days prior to study enrollment for which potential benefits of anticoagulation therapy to prevent recurrence of VTE are felt by the treating physician to exceed the potential harms
Any anticoagulation drug/strategy may be used to treat the index VTE; protocol treatment will begin <= 30days after the index VTE diagnosis date
Treating physician intends to put participant on anticoagulation therapy for at least three months.
Age >= 18 years
Platelet count is >= 50,000/mm^3 (<= 7 days prior to enrollment)
CrCl (Creatinine Clearance) is >= 15 ml/min (<= 7 days prior to enrollment)
Exclusion Criteria
Diagnosis of acute leukemia
Has ever received or is scheduled to receive an Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
Patients who have ever received an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) ARE eligible.
Patients who are scheduled to receive an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) are NOT eligible
Ongoing, clinically significant bleeding (CTCAE grade 3 or 4)
Ongoing therapy with a P-gp inhibitor (e.g., nelfinavir, indinavir, or saquinavir-protease inhibitors for HIV) as these drugs interact with the factor Xa inhibitors
Therapy with any azole antifungals (e.g., itraconazole, ketaconazole, voriconazole) at the time of enrollment
Additional locations may be listed on ClinicalTrials.gov for NCT02744092.
Locations matching your search criteria
United States
Minnesota
Minneapolis
University of Minnesota/Masonic Cancer Center
Status: Active
Name Not Available
North Carolina
Durham
Duke University Medical Center
Status: Active
Name Not Available
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.
