Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer
NCT02744092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 811
Last updated 2023-10-03
Summary
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.
Conditions
- Cancer
- Venous Thromboembolism
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism (PE)
- Blood Clot
Interventions
- DRUG
-
Rivaroxaban
Anticoagulation therapy.
- DRUG
-
Apixaban
Anticoagulation therapy.
- DRUG
-
Edoxaban
Anticoagulation therapy.
- DRUG
-
Dabigatran
Anticoagulation therapy.
- DRUG
-
Warfarin
Anticoagulation therapy.
- DRUG
-
Dalteparin
Anticoagulation therapy.
- DRUG
-
Enoxaparin
Anticoagulation therapy.
- DRUG
-
Fondaparinux
Anticoagulation therapy.
Sponsors & Collaborators
-
Patient-Centered Outcomes Research Institute
collaborator OTHER -
Alliance Foundation Trials, LLC.
lead OTHER
Principal Investigators
-
Deborah Schrag, MD MPH · Alliance Foundation Trials, LLC.
-
Jean Connors, MD · Alliance Foundation Trials, LLC.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-13
- Primary Completion
- 2020-10-31
- Completion
- 2021-02-22
Countries
- United States
Study Locations
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