NCT02744092
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer
NA
COMPLETED
NCT02744092
INTERVENTIONAL
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The intervention strategy is Direct Oral AntiCoagulants (DOAC) therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is low molecular weight heparin (LMWH) alone or with warfarin. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.
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
Cancer
Venous Thromboembolism
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Blood Clot
- TREATMENT
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- Type: DRUG
- Name: Rivaroxaban
- Description: Anticoagulation therapy.
- Arm Group Labels: Preference Cohort 1 (DOACs), Randomized Arm 1 (DOACs)
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- Type: DRUG
- Name: Apixaban
- Description: Anticoagulation therapy.
- Arm Group Labels: Preference Cohort 1 (DOACs), Randomized Arm 1 (DOACs)
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- Type: DRUG
- Name: Edoxaban
- Description: Anticoagulation therapy.
- Arm Group Labels: Preference Cohort 1 (DOACs), Randomized Arm 1 (DOACs)
-
- Type: DRUG
- Name: Dabigatran
- Description: Anticoagulation therapy.
- Arm Group Labels: Preference Cohort 1 (DOACs), Randomized Arm 1 (DOACs)
-
- Type: DRUG
- Name: Warfarin
- Description: Anticoagulation therapy.
- Arm Group Labels: Preference Cohort 2 (LMWH), Randomized Arm 2 (LMWH)
-
- Type: DRUG
- Name: Dalteparin
- Description: Anticoagulation therapy.
- Arm Group Labels: Preference Cohort 2 (LMWH), Randomized Arm 2 (LMWH)
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- Type: DRUG
- Name: Enoxaparin
- Description: Anticoagulation therapy.
- Arm Group Labels: Preference Cohort 2 (LMWH), Randomized Arm 2 (LMWH)
-
- Type: DRUG
- Name: Fondaparinux
- Description: Anticoagulation therapy.
- Arm Group Labels: Preference Cohort 2 (LMWH), Randomized Arm 2 (LMWH)
- Alliance Foundation Trials, LLC.