Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer

Completed · Not applicable

Conditions studied: Cancer, Venous Thromboembolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Blood Clot

In brief

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.

Key facts

Study ID

NCT02744092

Run by

Alliance Foundation Trials, LLC.

People needed

811

Starts

2016-12-13

Expected to finish

2021-02-22

Last updated by the study team

2023-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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
• South County Hematology — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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